Medtronic KDR651 Technical Manual

KAPPA® DR650 SERIES

198798002A_view.pdf

198798002A_view.pdf

Pacemaker Models KDR651/653/656

Product Information Manual

Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician (or
properly licensed practitioner).

Kappa®650 Series Pacemaker
Product Information Manual

Models KDR651, KDR653, and KDR656

3

This Product Information Manual is primarily intended as an
implantation manual. For programming information see the
Pacemaker Reference Guide that accompanies the programmer
software. It is primarily intended as a follow-up manual, and contains
further information on therapeutic and diagnostic features,
troubleshooting information, follow-up precautionary information,
and complete reference information.

The following are trademarks of Medtronic:

Capture Management, FAST, Implant Detection, Kappa, Marker
Channel, Medtronic, Medtronic Kappa, Medtronic Vision, Rate
Profile Optimization, Sensing Assurance, and Vision.

4

Table of Contents

Chapter 1 - Prescribing the Pacemaker 7

Device Description 8
Indications and Usage 9
Contraindications 10
Warnings and Precautions 10
Co-implantation with an Implantable Defibrillator 20
Adverse Events 22
Clinical Studies 25

Chapter 2 - Implanting the Pacemaker 29

Implantation Procedures 30
Implant Documentation 39
Parameter Programming at Implant 40
Medical Therapy Interactions 45
Assistance 48

Chapter 3 - Description 49

Pacing Mode Operations 50
Rate Responsive Pacing 52
Timing Operations 54
Pacing and Sensing Operations 58
Special Therapy Options 65

Chapter 4 - Pacemaker Follow-up 71

Pacemaker Telemetr y 72
Other Operations 75

5

Diagnostics 79
General Recommendations 80

Pacemaker Specifications 81

Lead Requirements, Compatibility 82
Radiopaque Identification 83
Emergency Parameter Settings 84
Shipping and Nominal Parameter Settings 85
Electrical Reset Parameter Settings 89
Elective Replacement Indicator 93
Magnet Mode Conditions 93
Longevity Projections 94
Programmable Parameters 96
Nonprogrammable Parameters 103
Temporary Parameters 104
Tel e m e tr y M a r k e rs 10 5
Electrograms 105
Automatic Diagnostics 105
Clinician-Selected Diagnostics 106
Patient Information 106
Battery and Lead Telemetered Information 107
Battery Parameters 108
Mechanical Dimensions 108

Appendix 109

NBG Codes 110
Special Notice 111

Index 113

6

Prescribing the Pacemaker

Chapter 1 - Prescribing the Pacemaker

Device Description 8

Indications and Usage 9

Contraindications 10

Warnings and Precautions 10

Co-implantation with an Implantable Defibrillator 20

Adverse Events 22

Clinical Studies 25

7

Prescribing the Pacemaker

Device Description

Medtronic Kappa 650 Series pacemakers (KDR650 Series) are dual
chamber, multiprogrammable, rate responsive, implantable
pacemakers, intended for a variety of bradycardia pacing
applications. Rate response is controlled through an activity-based
sensor. The following models are available:

Model Polarity Primary Leads

K

DR651 Bipolar/Unipolar IS-1

KDR653 Bipolar/Unipolar Low-profile 3.2 mm bipolar

K

DR656 Unipolar Unipolar 5 or 6 mm

a

IS-1 refers to an International Connector Standard (see Document No. ISO 5841-3;

1992).

DR650 Series pacemakers are programmed using the Medtronic

K
Vision software Model 9953 and a Medtronic Model 9790
programmer. For programming instructions, refer to the Pacemaker
Programming Guide that accompanies Medtronic Kappa 700/650
Series software.

a

or IS-1

BI

a

BI

8

Prescribing the Pacemaker

Indications and Usage

KDR650 Series pacemakers are indicated for the following:

■

Rate adaptive pacing in patients who may benefit from
increased pacing rates concurrent with increases in activity.

■

Accepted patient conditions warranting chronic cardiac pacing
which include:

– Symptomatic paroxysmal or permanent second or

third-degree AV block.
– Symptomatic bilateral bundle branch block.
– Symptomatic paroxysmal or transient sinus node

dysfunctions with or without associated AV conduction

disorders.
– Bradycardia-tachycardia syndrome to prevent

symptomatic bradycardia or some forms of symptomatic

tachyarrhythmias.

KDR650 Series pacemakers are also indicated for dual chamber and
atrial tracking modes in patients who may benefit from maintenance
of AV synchrony. Dual chamber modes are specifically indicated for
treatment of conduction disorders that require restoration of both rate
and AV synchrony, which include:

■

Various degrees of AV block to maintain the atrial contribution
to cardiac output.

■

VVI intolerance (e.g., pacemaker syndrome) in the presence of
persistent sinus rhythm.

9

Prescribing the Pacemaker

Contraindications

KDR650 Series pacemakers are contraindicated for the following
applications:

■

Dual chamber atrial pacing in patients with chronic refractory
atrial tachyarrhythmias.

■

Asynchronous pacing in the presence (or likelihood) of
competitive paced and intrinsic rhythms.

■

Unipolar pacing for patients with an implanted cardioverter­defibrillator (ICD) because it may cause unwanted delivery or
inhibition of ICD therapy. See “Co-implantation with an
Implantable Defibrillator” on page 20.

Warnings and Precautions

■

Rate responsive modes. Do not use rate responsive modes
in those patients who cannot tolerate pacing rates above the
programmed Lower Rate.

■

Single chamber atrial modes. Do not use single chamber
atrial modes in patients with impaired AV nodal conduction
because ventricular capture cannot be assured.

Pacemaker Dependent Patients

■

Diagnostic modes. Never program diagnostic modes (ODO,
OVO, and OAO) for pacemaker-dependent patients. For such
patients, use the programmer’s inhibit function for brief
interruption of outputs.

■

Electrogram (EGM) of the patient’s intrinsic activity should be
obtained with care since the patient is without pacing support
when using the programmer’s inhibit function.

■

Polarity override. Overriding the bipolar verification prompt
with bipolar polarity when a unipolar lead is connected results

10

Prescribing the Pacemaker

in no pacing output. See “Manually Programming Polarity” on
page 61 for further information.

■

A false bipolar pathway on a unipolar lead, a possible
occurrence with bipolar 3.2 mm connector pacemakers, may
result in a loss of output. See the warning in “Automatic
Polarity Configuration” on page 58 for further information.

■

Loss of capture during threshold margin test (TMT) at a
20% reduction in amplitude indicates that the stimulation
safety margin is inadequate. Consider increasing the pacing
amplitude and/or pulse width. See “Magnet Operation” on
page 75 for further information on the Threshold Margin Test.

■

Ventricular safety pacing should always be used for
pacemaker-dependent patients. See “Ventricular Safety
Pacing” on page 68 for further information.

■

Capture Management will not program ventricular outputs
above 5.0 V or 1.0 ms. If the patient needs a pacing output
higher than 5.0 V or 1.0 ms, program Amplitude and Pulse
Width manually. See “Capture Management” on page 64 for
further information

Medical Therapy

■

Therapeutic Diathermy can cause fibrillation, burning of
the myocardium, and irreversible damage to the pulse
generator due to induced currents.

■

Magnetic resonance imaging of pacemaker patients has
resulted in significant adverse effects. See “Magnetic
Resonance Imaging (MRI)” on page 16 for further information.

Storage and Resterilization

Medtronic pacemakers are intended for single use only. Do not
resterilize and re-implant explanted pacemakers.

The chart below gives recommendations on handling and storing the
package. Medtronic has sterilized the pacemaker with ethylene oxide

11

Prescribing the Pacemaker

prior to shipment. Resterilizing the pacemaker is necessary if the
seal on the sterile package is broken. Resterilization does not affect
the “Use Before” date.

Handling and Storage: Acceptable Unacceptable

Store and transport within
Environmental Temperature limits:

°F (- 18°C) to 131°F (55°C).

0
Note: A full or partial electrical reset

condition may occur at temperatures
below 0°F (- 18°C). See “Electrical
Reset Parameter Settings” on
page 89.

Resterilization: Acceptable Unacceptable

Resterilize if the sterile package seal
is broken. Place the device in an
ethylene oxide permeable package
and resterilize with ethylene oxide.
Allow the device to aerate ethylene
oxide residues. See sterilizer
instructions for details. Use an
acceptable method for determining
sterility, such as biological indicators.

Do not implant the device if it has
been dropped on a hard surface
from a height of 12 inches (30 cm)
or more.

Do not resterilize the device or
the torque wrench using:

• an autoclave,

• gamma radiation,

• organic cleaning agents, e.g.,
alcohol, acetone, etc.,

• ultra-sonic cleaners.

Do not exceed 140
17 psi (103 kPa) when sterilizing.

Do not resterilize the device more
than twice.

Lead Evaluation and Lead Connection

■

Connector compatibility. Do not use any lead with this
pacemaker without first verifying connector compatibility.
Using incompatible leads can damage the connector or result
in a leaking or intermittent connection.

°F (60°C) or

12

Prescribing the Pacemaker

■

Pacing and sensing safety margins. Consider lead
maturation when choosing pacing amplitudes, pacing pulse
widths, and sensing levels. See “Manual Programming” on
page 42.

■

Hex wrench. Do not use a hex wrench with a blue handle or a
right- angled hex wrench. These wrenches have torque
capabilities greater than is designed for the lead connector.
See “Connection Procedure” on page 33 for lead connection
instructions.

Programming and Pacemaker Operation

■

Epicardial leads. Ventricular epicardial leads have not been
determined appropriate for use with the Capture Management
feature. Therefore, Capture Management should be
programmed Off if epicardial leads are implanted with

DR650 Series pacemakers.

K

■

Shipping values. Do not use shipping values for pacing
amplitude and sensitivity without verifying that they provide
adequate safety margins for the patient.

■

Constant current devices. To test the performance of the
lead, Medtronic recommends using a constant voltage device
such as the Medtronic Model 5311B (or equivalent) Pacing
System Analyzer (PSA). Medtronic does not recommend using
a constant current device such as the Medtronic Model 5880A
or 5375 External Pacemaker because the K
pacemakers have constant voltage output circuits.

■

Crosstalk occurs in dual chamber systems when atrial pacing
output pulses are sensed by the ventricular lead. Crosstalk
results in self-inhibition and is more likely to occur at high
sensor-driven pacing rates, high atrial amplitudes, and wide
atrial pulse widths. To prevent self-inhibition caused by
crosstalk, program Ventricular Safety Pacing (VSP) On or
lengthen the Ventricular Blanking period.

DR650 Series

13

Prescribing the Pacemaker

■

Elective Replacement Indicator (ERI). When ERI is set, the
pacemaker must be replaced within three months. See
“Elective Replacement Indicator” on page 77 for more
information.

■

Full electrical reset is indicated by VVI pacing at a rate of
65 ppm without the elective replacement indicator set. See
“Electrical Reset” on page 77 for more information.

■

Slow retrograde conduction, especially with conduction time
greater than 400 ms, may induce pacemaker-mediated
tachycardia (PMT).

■

PMT intervention. Even with the feature turned On, PMTs
may still require clinical intervention such as pacemaker
reprogramming, magnet application, drug therapy, or lead
evaluation. See “PMT Intervention” on page 67 for further
information.

■

Lead Monitor. If the Lead Monitor detects out-of-range lead
impedance, investigate lead integrity more thoroughly.

Rate Increases

■

Twiddler’s syndrome, i.e., patient manipulation of the device
after implant, may cause the pacing rate to increase
temporarily if the pacemaker is programmed to a rate
responsive mode.

■

Muscle stimulation, e.g., due to unipolar pacing, may result in
pacing at rates up to the Upper Sensor Rate in rate responsive
modes.

Unipolar Sensing

■

Continuous myopotentials cause reversion to asynchronous
operation when sensed in the refractory period. Sensing of
myopotentials is more likely when atrial sensitivity settings of

0.5 through 1.0 mV and ventricular sensitivity settings of

1.0 and 1.4 mV are programmed.

14

Prescribing the Pacemaker

Environmental and Medical Therapy Hazards

Patients should be directed to exercise reasonable caution in
avoidance of devices which generate a strong electric or magnetic
field. If the pacemaker inhibits or reverts to asynchronous operation
at the programmed pacing rate or at the magnet rate while in the
presence of electromagnetic interference (EMI), moving away from
the source or turning it off will allow the pacemaker to return to its
normal mode of operation.

Hospital and Medical Environments

■

Electrosurgical cautery could induce ventricular arrhythmias
and/or fibrillation, or may cause asynchronous or inhibited
pacemaker operation. If use of electrocautery is necessary, the
current path and ground plate should be kept as far away from
the pacemaker and leads as possible. See “Electrosurgical
Cautery” on page 47 for more information.

■

External defibrillation may damage the pacemaker or may
result in temporary and/or permanent myocardial damage at
the electrode-tissue interface as well as temporary or
permanent elevated pacing thresholds. Attempt to minimize
current flowing through the pacemaker and lead system by
following these precautions when using external defibrillation
on a pacemaker patient:

– Position defibrillation paddles as far from the pacemaker as

possible (minimum of 5 inches [13 cm]). Attempt to
minimize current flowing through the pacemaker and leads
by positioning the defibrillation paddles perpendicular to
the implanted pacemaker/lead system.

– Use the lowest clinically appropriate energy output (watt

seconds).

– Confirm pacemaker function following any defibrillation.

■

High energy radiation sources such as cobalt 60 or gamma
radiation should not be directed at the pacemaker. If a patient
requires radiation therapy in the vicinity of the pacemaker,

15

Prescribing the Pacemaker

place lead shielding over the device to prevent radiation
damage and confirm its function after treatment.

■

Lithotripsy may permanently damage the pacemaker if the
device is at the focal point of the lithotripsy beam. If lithotripsy
must be used, program the pacemaker to a single chamber
nonrate responsive mode (VVI/AAI or VOO/AOO) prior to
treatment; and keep the pacemaker at least 1 to 2 inches
(2.5 to 5 cm) away from the focal point of the lithotripsy beam.

■

Magnetic resonance imaging (MRI). Pacemaker patients
subjected to MRI should be closely monitored and
programmed parameters should be verified upon cessation of
MRI. MRI of pacemaker patients should be carefully weighed
against the potential adverse affects. Clinicians should
carefully weigh the decision to use MRI with pacemaker
patients. Limited studies of the effects of MRI on pacemakers
have shown that:

– Magnetic and radio frequency (RF) fields produced by MRI

may adversely affect the operation of the pacemaker and
may inhibit pacing output.

– Magnetic fields may activate magnet mode operation and

cause asynchronous pacing.

– Reported

1

effects of MRI on pacing include increased

ventricular pacing beyond the rate limit.

1

Holmes, Hayes, Gray, et al. The effects of magnetic resonance imaging on implantable
pulse generators. PA C E. 1986; 9 (3): 360-370.

16

Prescribing the Pacemaker

■

Radiofrequency ablation procedure in a patient with a

DR650 Series pacemaker may cause any of the following:

K
– Asynchronous pacing above or below the

programmed rate.
– Reversion to an asynchronous operation.
– Pacemaker electrical reset.
– Premature triggering of the elective replacement indicator.

RF ablation risks may be minimized by:

1. Programming a non-rate responsive, asynchronous pacing
mode prior to the RF ablation procedure.

2. Avoiding direct contact between the ablation catheter and the
implanted lead or pacemaker.

3. Positioning the ground plate so that the current pathway does
not pass through or near the pacemaker system, i.e., place the
ground plate under the patient’s buttocks or legs.

4. Having a Medtronic programmer available for temporary
pacing.

5. Having defibrillation equipment available.

Home and Occupational Environments

■

High voltage power transmission lines may generate
enough EMI to interfere with pacemaker operation if
approached too closely.

■

Communication equipment such as microwave transmitters,
linear power amplifiers, or high-power amateur transmitters
may generate enough EMI to interfere with pacemaker
operation if approached too closely.

■

Commercial electrical equipment such as arc welders,
induction furnaces, or resistance welders may generate
enough EMI to interfere with pacemaker operation if
approached too closely.

17

Prescribing the Pacemaker

■

Home appliances which are in good working order and
properly grounded do not usually produce enough EMI to
interfere with pacemaker operation. There are reports of
pacemaker disturbances caused by electric hand tools or
electric razors used directly over the pacemaker implant site.

■

Electronic article surveillance (EAS) equipment such as
retail theft prevention systems may interact with pacemakers.
Patients should be advised to walk directly through and not to
remain near an EAS system longer than is necessary.

Cellular Phones

Note: Testing was not performed on the K

to similarity in design and function to the K
data collected for the K

DR700 Series models therefore supports the

DR650 Series models due

DR700 Series models. The

safety and efficacy claims for the KDR650 Series models and is
included here for reference purposes.

DR700 Series pacemakers have been tested to the frequency

K
ranges used by the cellular phones included in Table 1. Based on this
testing, these pacemakers should not be affected by the normal
operation of such cellular phones.

These pacemakers contain a filter that allows usage, without
interaction, of all cellular phones having one of the transmission
technologies listed in Table 1. These transmission technologies
represent most of the cellular phones in use worldwide. Patients can
contact their local cellular phone service provider to confirm that the
provider uses one of these technologies.

18

Prescribing the Pacemaker

Table 1. Cellular Phone Transmission Technologies

Transmission Technology Frequency Range

Analog

FM (Frequency Modulation) 824 - 849 MHz

Digital TDMA

North American Standards

TDMA - 11 Hz 806 - 821 MHz

NADC

PCS

International Standards

GSM

DCS

a

b

(TDMA - 50 Hz)

c

1900

d

e

1800

824 - 849 MHz

1850 - 1910 MHz

880 - 915 MHz

1710 - 1785 MHz

Digital CDMA

CDMA - DS

a

Time Division Multiple Access

b

North American Digital Cellular

c

Personal Communication System

d

Global System for Mobile Communications

e

Digital Cellular System

f

Code Division Multiple Access - Direct Sequence

f

824 - 849 MHz

19

Prescribing the Pacemaker

Co-implantation with an Implantable Defibrillator

■

An implantable defibrillator may be implanted concomitantly
with a bipolar pacemaker.

– The use of unipolar-only Model KDR656 and the

DR650 Series bipolar models implanted with unipolar

K
leads is contraindicated for patients having an implantable
defibrillator.

– Follow implant protocol and precautions for pacemaker

and defibrillator lead placement. Ensure the pacemaker is
configured to be compatible with the defibrillator.

Programming Considerations

Note the following programming considerations for patients who have
an implantable defibrillator.

■

Only bipolar pacing should be used with these patients. In
some cases, pacing in the unipolar configuration may cause
the defibrillator either to deliver inappropriate therapy or to
withhold appropriate therapy.

■

Polarity is automatically configured during Implant Detection
(see “Automatic Polarity Configuration” on page 58 of the
Product Information Manual). If lead integrity is suspect,
confirmation of the automatically programmed polarities
should be made after completion of Implant Detection in order
to assure that bipolar polarities have been programmed
appropriately.

■

The implantable cardiac defibrillator (ICD) should be turned off
during pacemaker implantation procedures until lead polarities
have been configured and confirmed. This is to prevent
possible back-up unipolar paces from triggering the ICD.

■

Lead Monitor should not be programmed to Adaptive. When a
prevalence of out-of-range lead impedance paces is detected,

20

Prescribing the Pacemaker

the monitor automatically reprograms the selected lead(s) to
unipolar polarity. Pacing in the unipolar configuration may
cause the defibrillator either to provoke inappropriate therapy
or to withhold appropriate therapy.

■

Transtelephonic Monitor should be programmed to Off. If it is
programmed On, the pacing polarity is temporarily set to
unipolar when the magnet is applied. Pacing in the unipolar
configuration may cause the defibrillator either to provoke
inappropriate therapy or to withhold appropriate therapy.

■

Although these pacemakers are designed to be compatible
with implantable defibrillators, the potential does exist for a
defibrillation pulse to reset them.

– If a partial electrical reset occurs, these pacemakers

implanted with bipolar leads will retain atrial and ventricular
bipolar pacing polarities.

– If a full electrical reset occurs, these pacemakers

implanted with bipolar leads will reset to Implant Detection.
If lead integrity is suspect, confirmation of bipolar polarity
should be made after completion of Implant Detection.

21

Prescribing the Pacemaker

Adverse Events

The Medtronic Kappa 700 Series devices were evaluated in a
multicenter prospective study (43 investigational centers, 15 centers
in the US) of the adaptive features and rate response of the device.
Clinical study of the Medtronic Kappa 700 Series of pacemakers
included 288 devices implanted in 285 patients worldwide.

Note: Clinical studies were not performed on the K
series models due to similarity in design and function to the K
Series models. The clinical data collected for the K
models therefore supports the safety and efficacy claims for the

DR650 Series models and is included here for reference purposes.

K

There were a total of six deaths in the KDR700 Series study; all were
reviewed and judged to be non-device related by a clinical events
committee comprising clinical investigators and Medtronic clinical
evaluation managers. Two were attributed to ventricular arrhythmia,
one to respiratory failure, the fourth to respiratory insufficiency due to
chronic obstructive pulmonary disease, the fifth to a mesotelioma,
and the sixth to multi-system organ failure.

Eight devices were explanted: three due to pocket infection, one due
to infection of the electrode, one from lead/connector mismatch, one
patient had a psychosomatic disorder, one patient required the
implant of a dual chamber ICD, and one patient continued with
vasovagal symptoms and the therapy did not provide sufficient
benefit.

DR650 Series

DR700

DR700 Series

Observed Adverse Events

A total of 355 adverse events were reported. The device-related
events (182 events) are listed in descending order of frequency in
Ta bl e 2 .

22

Prescribing the Pacemaker

Tab le 2. Adverse Events Reported in Four or More Patients- Complicationsa

(Comps) and Observations

All patients implanted (n=288 devices in 285 patients, 133 device years)

c

% of

Patients

with
Comps
(n=285)

Event Total

Number

of

Events

(Patients)

Any adverse

355 (168) 17.2% 0.45 52% 2.22

b

(Obs)

Comps

per

Device-

Year

(n=133)

% of

Patients

with Obs

(n=285)

Obs per

Device-

Year

(n=133)

events

Any device-related

182 (118) 10.9% 0.31 34% 1.06

events

Pain at pocket site 32 (31) — — 10.9% 0.24

Other 23 (21) 1.1% 0.02 6.3% 0.15

Inappropriate

11 (11) — — 3.9% 0.08

programming

Atrial lead

11 (10) 3.6% 0.08 — —

dislodgment

Programmer/
software anomaly

11 (8) — — 2.8% 0.08

d

Pocket infection 7 (6) 0.7% 0.02 1.4% 0.03

Intermittent

6 (6) 0.7% 0.02 1.4% 0.03

undersensing

Palpitations 6 (6) — — 2.1% 0.05

Pocket hematoma 6 (6) 0.4% 0.01 1.8% 0.04

Ventricular lead

6 (6) 2.1% 0.05 — —

dislodgment

Elevated pacing

4 (4) 0.7% 0.02 0.7% 0.02

thresholds

Syncope 4 (4) — — 1.4% 0.03

23

Prescribing the Pacemaker

a

Complications included those adverse events which required invasive measures to
correct (e.g., surgical intervention), and were related to the presence of the pacing
system or procedure.

b

Observations included those adverse events which did not require invasive measures
to resolve, and were related to the presence of the pacing system or procedure.

c

Where present, a number in parentheses indicates the number of patients with the
event.

d

Programmer software anomalies observed: screen lock-ups while saving data to
diskette (8); problems printing reports outside of a patient session (2); and an incorrect
parameter setting on a printout (1), which occurred in an earlier version of the
software—software changes were made to eliminate reoccurrence.

The following other adverse events were reported, but occurred in
three or fewer patients: angina pectoris; atrial flutter (paroxysmal)/
atrial fibrillation; bipolar short circuit pathway; chest pain; chest pain
(non-specific); dizziness; dyspnea/shortness of breath; exit block;
failure to capture/loss of capture; false negative capture detection; far
field R-wave sensing; fatigue/tiredness; hypotension; inadequate
lead/pacemaker connection; infection of electrode; lead/connector
mismatch; lead insertion route problem; lead insulation failure;
migration of pulse generator; myopotential interference; other
oversensing; pacemaker mediated tachycardia; pacemaker
syndrome; pectoral muscle stimulation; penetration of myocardium
by lead; phrenic nerve/diaphragm muscle stimulation;
pneumothorax; swelling pocket site; tachycardia (atrial); thrombus
formation at lead; ventricular ectopy; ventricular tachycardia
(non-sustained); ventricular tachycardia (sustained).

The following adverse events were deemed not device related
(173 events were reported): angina pectoris; atrial fibrillation; atrial
flutter (paroxysmal); atrial flutter (persistent); atrial tachycardia; chest
pain; chest pain (non-specific); congestive heart failure; dizziness;
dyspnea/shortness of breath; fatigue/tiredness; hypertension;
hypotension; insufficient cardiac output; myocardial infarction
(acute); palpitations; syncope; ventricular ectopy; ventricular
fibrillation; ventricular tachycardia (non-sustained); ventricular
tachycardia (sustained).

24

Prescribing the Pacemaker

Potential Adverse Events

Adverse events (in alphabetical order), including those reported in
Table 2, associated with pacing systems include:

■

Cardiac perforation

■

Cardiac tamponade

■

Death

■

Erosion through the skin

■

Hematoma/seroma

■

Infection

■

Myopotential sensing

■

Nerve and muscle stimulation

■

Rejection phenomena (local tissue reaction, fibrotic tissue
formation, pulse generator migration)

■

Threshold elevation

■

Transvenous lead-related thrombosis

Clinical Studies

The Medtronic Kappa 700 Series devices were evaluated in a
multicenter prospective study (43 investigational centers, 15 centers
in the US) of the adaptive features and rate response of the device.

Note: Clinical studies were not performed on the K
models due to similarity in design and function to the K
models. The clinical data collected for the K
therefore supports the safety and efficacy claims for the K
series models and is included here for reference purposes.

DR650 series

DR700 series

DR700 series models

DR650

25

Prescribing the Pacemaker

Methods

This study compared the following features of the Medtronic Kappa
700 Series pacemakers to historical controls:

■

Rate Response

■

Capture Management

■

Automatic Polarity Configuration

■

Sensing Assurance

Patient data were collected at implant, pre-discharge, two weeks,
one month, two and/or three months, and six months post implant.
Patients were evaluated utilizing a modified version of the Minnesota
Pacemaker Response Exercise Protocol (MPREP

1

) at their one
month visit. Evaluation of rate response performance for the
Medtronic Kappa 700 Series pacemaker was conducted using the
Metabolic Chronotropic model described by Wilkoff as applied by

2

. Automatic polarity configuration data were collected at implant.

Kay
Sensing Assurance and Capture Management data were collected at
each follow-up.

Description of Patients

Patients enrolled in the study represented a general dual chamber
pacing population.

Results of the Study

Table 3 summarizes the results of the clinical study. The incidence of
complications was found to be similar to that experienced by similar
devices. The performance of the automatic polarity configuration,
Capture Management, Sensing Assurance, and rate response
features were found to meet study objectives.

1

Benditt, David G. M, Editor, Rate Adaptive Pacing, Blackwell Scientific Publications,
Boston. 1993: 63-65.

2

Kay, Neal G., “Quantitation of Chronotropic Response: Comparison of Methods for
Rate-Modulating Permanent Pacemakers”, JACC 20(7):1533-41, Dec 1992.

26

Prescribing the Pacemaker

The slope of the exercise rate response (1.0 target slope) was less
than 0.65 for 26 of 87 (30%) of patients.

All patients implanted (n=288 devices in 285 patients, 133 device years)

Primary Objectives

Automatic Polarity Configuration (n with loss of output / N leads)

Total Leads 0% (0/546) [0%, 0.55%] ≤5%

Unipolar 0% (0/107) [0%, 2.8%] ≤5%

Bipolar 0% (0/439) [0%, 0.7%] ≤5%

Sensing Assurance

(n with loss of sensing or oversensing / N device years)

Atrial 13.5% (18/133) [8.8%, 20.5%] ≤35.7%

Ventricular 0.8% (1/133) [0.2%, 4.1%] ≤9.2%

Capture Management (n with all causes loss of capture / N device years)

Loss of capture 5.3% (7/133) [2.6%, 10.5%] ≤10.7%

Slope of MPREP rate response at 1 month (n=87 patients)

Mean 0.81 [0.76, 0.86] [0.65, 1.35]

Table 3. Effectiveness Analysis

Percent of

events

% (n/N)

95%

Confidence

interval

Criteria:

Upper

95% CI

27

Prescribing the Pacemaker

The Medtronic Kappa 700 Series pacemaker’s Rate Profile
Optimization (RPO) governs sensor indicated rate (SIR) output. This
function is identical in the K

DR650 Series pacemakers. Figure 1

shows the SIR vs. the Wilkoff predicted heart rate achieved using the
RPO feature during the MPREP tests at 1 month.

All patients reaching Anaerobic Threshold, N=87

Expected (Wilkoff) rate, mean and 95% CI

100

90

80

70

CI

60

50

40

30

SIR (normalized)

20

10

0

0 204060

%

5

9

r

pe

p

U

n

a

e

M

Lower 95% CI

E

N

(

R

I

S

W

(

d

e

t

c

e

p

x

)

7

8

=

80

MPREP Workload (normalized)

Figure 1. Sensor Indicated Rate (SIR) vs. Expected Rate at One Month

R

I

S

)

f

f

o

k

l

i

100

28

Implanting the Pacemaker

Chapter 2 - Implanting the Pacemaker

Implantation Procedures 30

Implant Documentation 39

Parameter Programming at Implant 40

Medical Therapy Interactions 45

Assistance 48

29

Implanting the Pacemaker

Implantation Procedures

Testing Leads and Pacemaker

Equipment to Test the Pacemaker and Lead

To test the performance of the lead, Medtronic recommends using a
constant voltage device such as the Medtronic Model 5311B (or
equivalent) Pacing System Analyzer (PSA).

Caution: Do not use constant current devices (such as the
Medtronic external pacemaker Models 5880A, 5375, 5348, or 5346)
to test lead performance. They may damage the pacemaker’s
constant voltage output circuits.

For further procedures on determining thresholds and analyzing
pacemaker operation, consult the PSA technical manual.

Note: Wait at least 15 minutes after implanting screw-in leads
(nonsteroid) before measuring final stimulation thresholds and
intracardiac sensing potentials.

Determining Stimulation Threshold

While testing the lead system prior to implant, Medtronic
recommends taking and verifying threshold measurements in both
the unipolar and bipolar polarities for all of the pacemaker models.
Stimulation thresholds less than 1.0 V at a 0.5 ms pulse width are
recommended for acute ventricular leads. Atrial leads may have
slightly higher stimulation thresholds.

Test for the following configurations:

■

Lead tip to case (for unipolar pacing and sensing).

■

Lead tip to lead ring (for bipolar pacing and sensing).

If the stimulation threshold of a mature chronic lead exceeds 2.5 V at
a pulse width of 0.5 ms, consider replacing the lead.

Note: Low-profile 3.2 mm bipolar and IS-1 BI leads can be
connected to the pacemaker in only one way, i.e., distal (tip)

30

Implanting the Pacemaker

electrode to the negative terminal. Because of this, the negative clip
of the PSA connecting cable must be connected to the lead
connector pin for correct threshold measurement. (See PSA
technical manual for more information.)

Determining Lead Impedance

Acute lead impedance or pacing impedance for standard leads
should typically fall between 250 and 1000 ohms, although it may fall
outside this range for short periods of time.

Acute lead impedance for leads designed with impedance at or
greater than 1000 ohms should typically fall between 500 and
2500 ohms. High impedances with these leads are acceptable as
long as stimulation and sensing thresholds are acceptable.

If the lead or pacing impedance remains outside of the
recommended range, reposition or replace the lead.

Determining Intracardiac Sensing Potentials

The intracardiac signal must be of sufficient strength to be sensed by
the pacemaker. Intracardiac signals on chronic leads have a lesser
magnitude and slew rate.

Note: Acceptable stimulation thresholds are not an indication of
adequate sensing potentials.

31

Implanting the Pacemaker

Analyzing Pacemaker Operation

Before connecting the leads, check the pacemaker for proper
operation with a Medtronic Model 5311B (or equivalent) Pacing
System Analyzer (PSA). Note that specifications for device operation
apply at body temperature. As a result, some variance may occur if
measurements are taken at room temperature.

During this test, the setscrew(s) in the connector assembly must
contact the PSA’s cable probes. Use the appropriate cable probes to
match the connector ports for the K

DR650 Series models.

Connecting Leads to the Pacemaker

The Model KDR651 connector assembly accepts IS-1 BI leads. The
Model K
BI leads. The Model KDR656 accepts 5 or 6 mm unipolar leads or
IS-1 leads with the appropriate sizing sleeves.

The K
ports. Models K
contact aligned behind one another. (See Figure 2.)

DR653 accepts either low-profile 3.2 mm bipolar leads or IS-1

DR650 Series pacemakers each have two lead connector

DR651 and KDR653 have a tip and ring connector

32

Implanting the Pacemaker

Tip Electrodes

Ring Electrodes

Atrial Port

Ventricular Por t

Figure 2. Example of Bipolar Connector Assembly for Model KDR651

Model KDR651 uses a setscrew to contact the lead tip electrode, but
does not use a setscrew to contact the ring electrode. Model K

DR653

contacts the lead with setscrews at the tip and ring electrodes.

Connection Procedure

Lead connection consists of three steps:

1. Insert the provided torque wrench into the bisected grommet
as shown in Figure 3.

a. Check that the setscrew is retracted from the connector

port by visual inspection of the opening. If a setscrew is
obstructing the pathway, rotate the setscrew
counterclockwise one or two revolutions until the opening
is no longer obstructed.

Note: Counterclockwise rotation beyond this point may
disengage the setscrew from the connector block.

b. Eliminate the “piston effect” (difficulty in inserting the lead

due to compression of trapped air in the connector port)
when the lead is inserted by leaving the torque wrench in
the distal grommet until the lead is secure. This allows a
pathway for venting trapped air when the lead is inserted.

33

Implanting the Pacemaker

The rubber connector seal maintains the torque wrench in
position.

a

Figure 3. Connector Port Setscrew Preparation

b

2. Push the lead into the connector port until the lead pin is

clearly visible in the pin viewing area as indicated by arrows in
Figure 4 and described in the table below.

Note: Lubricating the lead end with sterile water may ease
lead insertion.

Lead-Pin Tip Placement In Pin Viewing Area

Model K

DR651 IS-1 BI Visible at end of area

Model K

DR653 IS-1 BI Just becomes visible

Low-profile

3.2 mm bipolar

DR656 5 or 6 mm unipolar Visible at end of area

Model K

Visible at end of area

34

Implanting the Pacemaker

KDR651

K

DR656

K

DR653

(IS-1 BI leads)

Figure 4. Lead Insertion Viewing Area

(with 3.2 mm bipolar leads)

KDR653

3. Tighten the setscrew by turning clockwise until the torque
wrench clicks as indicated in Figure 5. The setscrew(s) must

be engaged for pacing to begin. Do not pull on the lead until all
setscrews have been tightened.

35

Implanting the Pacemaker

KDR651

DR656

K

DR653

K

Figure 5. Tightening Setscrews

Caution: Do not overtighten the setscrew(s). Do not use blue
handled or right angled hex wrenches, since they have torque
capabilities greater than is designed for this connector. The
torque wrench supplied with the pacemaker is designed to slip
when over-torqued to prevent damage to the socket or the
setscrews. Bending the wrench may break it.

36

Implanting the Pacemaker

Pacemaker Implantation

Proper placement can help facilitate lead wrap and prevent muscle
stimulation and device migration.

Pacemaker Orientation

The pacemaker may be used in either right or left pectoral implants.
Either side of the shield can face the skin to facilitate excess lead
wrap. However, pacemakers with an insulative coating must be
implanted with the uncoated side facing the patient’s skin.

Avoiding Muscle Stimulation

If the patient experiences muscle stimulation while being paced in the
unipolar configuration, program the device to lower output settings,
such as a lesser Amplitude and/or narrower Pulse Width, without
compromising the patient’s stimulation safety margin.

Securing the Pacemaker (Suture Hole)

A suture placed through the suture hole located in the connector
assembly area helps secure the pacemaker in the subcutaneous
pocket, thus minimizing post-implant rotation and migration of the
device. Use normal surgical needles to penetrate the suture hole.

Replacing an Implanted Pacemaker

When replacing a pacemaker:

1. Program the pacemaker to a nonrate responsive mode prior to
explantation if previously programmed to a rate responsive
mode. This avoids any potential rate increase while handling
the pacemaker.

2. Insert the proper wrench through each slit in the rubber
grommet and loosen each setscrew by turning
counterclockwise.

3. Gently retract the lead from the pacemaker connector.

37

Implanting the Pacemaker

4. If the lead pin shows signs of pitting or corrosion, the entire
lead should be discarded and replaced with a new lead to
assure the integrity of the pacing system.

5. Measure stimulation thresholds and sensing potentials.

6. Pacemaker-dependent patients will be without pacing
support when the lead is disconnected. Therefore, have a
temporary external pacing instrument available for use.

Caution: Electrosurgical cautery could induce ventricular

arrhythmias and/or fibrillation, or may cause asynchronous or
inhibited pacemaker operation. Refer to “Electrosurgical Cautery” on
page 47 for information on electrocautery use.

When replacing a Medtronic pacemaker or a pacemaker from
another manufacturer, the physician may require a lead adaptor kit to
connect the pacemaker to the chronic lead. Use the appropriate hex
wrench or screwdriver to disconnect the chronic lead. Medtronic
provides such wrenches in adaptor kits for use with pacemakers
manufactured by Biotronik, Coratomic, Guidant, Intermedics, St.
Jude/Pacesetter, Telectronics/Cordis, and Vitatron. See the
Medtronic publication Pacemaker and Connector Encyclopedia
under “Adaptors and Accessories” for the appropriate adaptor kits.

For questions about lead and pacemaker compatibility, consult your
Medtronic representative, or call Medtronic Technical Services.

38

Implanting the Pacemaker

Disposal of Pacemaker

When replacing the pacemaker (due to battery depletion or
explanting the pacemaker at the death of the patient who is to be
cremated), return the pacemaker to Medtronic for analysis and
disposal. Medtronic recommends cleaning and sterilizing the
pacemakers before returning. See the back cover for mailing
addresses.

Implant Documentation

Pacemaker Registration

A registration form is included in the shipping package for each
Medtronic implantable pacemaker. Upon completion of the
registration form by the clinician, this form serves as a permanent
record of facts related to the implanted device. A copy of this form
should be returned to Medtronic, where vital information will be
transferred to a wallet-size, plastic-coated pacemaker Identification
Card which will be mailed directly to the patient. A temporary
identification card is included in the shipping package for use by the
patient until the permanent card arrives. Refer to the back cover for
mailing addresses.

Establishing a Patient Record

At the time of implant the clinician should establish a record of the
patient’s pacemaker programmed parameter settings for later
reference. A patient record can give the clinician an accurate account
of the patient’s medical history at subsequent follow-ups when
evaluating the pacemaker’s performance. The registration form
should not serve this purpose since the form is intended for
registering the patient and pacemaker with Medtronic.

39

Implanting the Pacemaker

Parameter Programming at Implant

Shipping Parameters

The pacemaker is configured to a set of shipping parameters at the
time of manufacture. At implant the device operates at these settings
unless reprogrammed prior to implant. Refer to“Shipping and
Nominal Parameter Settings” on page 85 for specific shipping
parameter settings.

In the event that the pacemaker is not configured to shipping settings
at implant, the device may have changed to partial or full electrical
reset settings due to extreme temperatures or intense
electromagnetic interference.

Caution: If, at implant, a programmer interrogation indicates the
pacemaker has been reset to VVI, 65 ppm full electrical reset
settings, use the programmer to reset the device and reprogram the
previous mode and pacing operations. If, after a reset, a message
appears on the programmer screen/printout indicating the Date/Time
memory has been altered, contact your Medtronic representative for
further information.

Implant Detection

Implant Detection is a 30-minute period, beginning at lead insertion,
during which the pacemaker verifies that a lead(s) has been
connected by measuring lead impedance. After 30 minutes of
continuous lead connection, the pacemaker completes Implant
Detection and activates the pacemaker’s automatic features listed in
“Automatic Operation” on page 41.

40

Implanting the Pacemaker

Automatic Operation

At the completion of Implant Detection, these features are
automatically enabled or begin adaptation from their shipping
settings.

■

Operating polarities, which are determined during Implant
Detection, are confirmed at its completion.

■

Mode becomes DDDR (though shipped in the DDDR mode,
the device effectively operates in the DDD mode until Implant
Detection is completed).

■

Rate Profile Optimization is enabled.

■

Capture Management is enabled and begins monitoring
ventricular pacing thresholds.

■

Sensing Assurance is enabled, and Sensitivity becomes
adaptive.

■

Diagnostics are enabled.

If the physician manually programs Implant Detection to Off/
Complete during the 30-minute detect time, the automatic operation
of the above features will be activated at that time. If a programming
session is initiated at any time during Implant Detection, the
pacemaker will reset Implant Detection.

41

Implanting the Pacemaker

Manual Programming

If pacing rates, pacing outputs, and sensitivities are manually
programmed at implant, the physician should be aware of the
following programming considerations:

Pacing Rates

Program the Lower Rate to a setting that permits the patient to sleep
comfortably or program the Sleep Function On. Program ADL Rate
to provide adequate cardiac output during typical patient activity.
Program the Upper Sensor Rate and Upper Tracking Rate to provide
cardiac output that meets the patient’s metabolic demand during
exercise without provoking symptoms (e.g., angina).

Note: For patients with stable angina, program the Upper Sensor
Rate and Upper Tracking Rate to a value below the rate at which
angina occurs.

Programming a combination of high Upper Sensor Rate and Upper
Tracking Rate and a long refractory period may result in a shorter
“sensing window.” Loss of sensing in such cases could result in
competitive pacing. Programming PVARP to “varied” may minimize
competitive pacing.

Programming the Upper Tracking Rate to a value greater than the
Upper Sensor Rate has the effect of allowing the atrial rhythm to be
tracked to a rate higher than the sensor-driven rate.

Pacing Outputs

Strive for acute ventricular stimulation thresholds of 1.0 V amplitudes
at 0.5 ms pulse widths. Atrial stimulation thresholds may be slightly
higher. Do not use chronic atrial or ventricular leads if the stimulation
thresholds exceed 2.5 V amplitude at 0.5 ms pulse width.

The clinician should consider programming the pacemaker’s atrial
and ventricular outputs to allow 2:1 voltage safety margins above the
measured stimulation threshold values. Capture Management can

42

Implanting the Pacemaker

also be programmed to provide ongoing ventricular capture
monitoring and adjustment.

Capture Management can also be programmed to provide ongoing
ventricular capture monitoring and adjustment.

Sensitivity

Intracardiac signal amplitudes and slew rates decrease during the
lead maturation process. The clinician should consider 2:1 or 3:1
atrial and ventricular sensitivity safety margins when selecting
sensitivity settings, especially with acute leads. After establishing the
intracardiac sensing thresholds, the clinician may wish to program
the Atrial and Ventricular Sensitivities to more sensitive settings (i.e.,
lower numerical settings than the measured sensing thresholds).
Weigh these lower settings against the possibility of oversensing
noise and electromagnetic interference, especially with unipolar
sensing.

Ventricular Sensitivities of 1.0 mV or 1.4 mV with wide Atrial Pulse
Widths or high Atrial Amplitudes may result in ventricular safety
pacing with some lead systems at high sensor-driven pacing rates.
Reprogramming ventricular Sensitivity to a less sensitive setting
(higher numerical value) is one option under such circumstances.
Other options include programming a longer Ventricular Blanking
period.

Note: Adequate intracardiac signals should be present in both the
unipolar and bipolar polarities when using bipolar leads. Measure
sensing potentials in the unipolar polarity (lead tip to case) and
bipolar polarity (lead tip to lead ring) prior to connecting the leads.

43

Implanting the Pacemaker

Self-Inhibition

Self-inhibition in single chamber modes results from the sensing of
the pacing output pulse. This is more likely to occur with high
amplitudes, wide pulse widths, and low sensitivity settings.
Reprogramming the Sensitivity to a less sensitive setting (higher
numeric value) will usually resolve the situation.

In addition, inhibition can occur when far-field R-waves are sensed in
AAIR, ADIR, AAI, and ADI modes. This can be prevented by proper
programming of the single chamber Atrial Refractory Period and
Atrial Blanking.

Muscle Stimulation with Unipolar Pacing

Under certain circumstances (e.g., high output settings), pacemaker­induced muscle stimulation may occur at the pocket site with the
pacemaker programmed to ventricular unipolar pacing. Pacemaker­induced muscle stimulation may be effectively controlled and/or
eliminated by programming Pulse Width to a narrower setting or
programming a lower Amplitude.

Adapting Other Parameters

In addition to programming those parameters discussed above, the
physician should consider adjusting other nominal parameters based
on the patient’s history, medical condition, lifestyle, and
hemodynamic potential and need.

■

Rate response parameters: Rate Profile Optimization (ADL
Response and Exertion Response), Activity Threshold, Activity
Acceleration, and Activity Deceleration.

■

Timing intervals: Sensed AV (SAV) interval and Paced AV
(PAV) interval, and Rate Adaptive AV (RAAV).

■

Refractory and blanking periods: Ventricular Refractory
Period, Ventricular Blanking, Post-Ventricular Atrial Refractory
Period and Post-Ventricular Atrial Blanking.

44

Implanting the Pacemaker

In addition, the physician should consider programming several other
pacing features appropriate to the patient’s special pacing needs.
These features might include:

■

Mode Switch for managing atrial arrhythmias, and

■

Sleep Function and Single Chamber Hysteresis for other
pacing operations during inactivity.

Note: Non-Competitive Atrial Pacing, PVC Response, and
Ventricular Safety Pacing are On/Off features that are programmed
On at the time of manufacture.

Medical Therapy Interactions

This section provides details on possible interactions between
pacemaker therapy and other medical therapies.

Implantable Defibrillators

Some pacemaker patients may also require therapy from an
implantable defibrillator. Only bipolar pacing should be used with
these patients. In some cases, pacing in the unipolar configuration
may cause the defibrillator either to deliver inappropriate therapy or
to withhold appropriate therapy.

Regarding use of K
implantable defibrillator, note the following:

■

The use of unipolar-only Model KDR656 and the Models

DR651 and KDR653 implanted with unipolar leads is

K
contraindicated for patients having an implantable defibrillator.

■

The Models KDR651 and KDR653 implanted with bipolar leads
may be used in patients having an implantable defibrillator.
With these pacemakers, however, polarity is automatically
configured during Implant Detection. (See “Automatic Polarity
Configuration” on page 58.) If lead integrity is suspect,
confirmation of the automatically programmed polarities
should be made after completion of Implant Detection in order

DR650 Series models in patients having an

45

Implanting the Pacemaker

to assure that bipolar polarities have been programmed
appropriately.

■

The implantable cardiac defibrillator (ICD) should be turned off
during pacemaker implantation procedures until lead polarities
have been configured and confirmed. This is to prevent
possible back-up unipolar paces from triggering the ICD.

■

Although these pacemakers are designed to be compatible
with implantable defibrillators, the potential does exist for a
defibrillation pulse to reset them.

– If a partial electrical reset occurs, these pacemakers

implanted with bipolar leads will retain atrial and ventricular
bipolar pacing polarities.

– If a full electrical reset occurs, these pacemakers

implanted with bipolar leads will reset to Implant Detection.
If lead integrity is suspect, confirmation of bipolar polarity
should be made after completion of Implant Detection.

■

Follow implant protocol and precautions for pacemaker and
defibrillator lead placement. Ensure the pacemaker is
configured to be compatible with the defibrillator.

Warning: Lead Monitor should not be programmed to Adaptive.
When a prevalence of out-of-range lead impedance paces is
detected, the monitor automatically reprograms the selected lead(s)
to unipolar polarity. Pacing in the unipolar configuration may cause
the defibrillator either to provoke inappropriate therapy or to withhold
appropriate therapy.

Warning: Programming Transtelephonic Monitor On is
contraindicated for patients with implantable defibrillators. When it is
programmed On, the pacing polarity is temporarily set to unipolar
when the magnet is applied. Pacing in the unipolar configuration may
cause the defibrillator either to provoke inappropriate therapy or to
withhold appropriate therapy.

46

Implanting the Pacemaker

Electrosurgical Cautery

Electrocautery may cause permanent loss of output prior to
explanting the pacemaker and can induce ventricular fibrillation. The
electrocautery tip should never be used within 6 inches (15 cm) of an
implanted pacemaker/lead system.

The use of electrocautery may cause any of the following:
triggered or inhibited output, a temporary pause in output,
permanent loss of output, a rate in excess of the 200 ppm rate
limit, reversion to asynchronous operation, an electrical reset,
or premature triggering of the elective replacement indicator.

Because of these potential complications, alternatives to
electrocautery should be used when available.

Effects to the pacemaker vary considerably based on the type of
electrocautery unit, coagulation and cutting current settings, current
pathway from the cautery tip to the indifferent plate, and the
pacemaker/lead system. Electrocautery units could also interfere
with ECG monitoring equipment. Monitor cardiac activity via blood
pressure or pressure pulses when using electrocautery.

If electrocautery cannot be avoided, follow these steps to minimize
complications:

1. Program the device to the VOO/AOO (non-rate responsive)
mode beforehand and avoid direct contact with the pacemaker
or leads to avoid induction of tachyarrhythmias and/or
fibrillation.

2. Position the ground plate so that the current pathway does not
pass through or near the pacemaker system, i.e., place ground
plate under the patient’s buttocks or legs during abdominal
surgery.

3. Use short, intermittent, and irregular bursts at the lowest
feasible energy levels.

4. Use a bipolar electrocautery system, where possible.

5. Have temporary pacing and defibrillation equipment available.

47

Implanting the Pacemaker

X-ray and Fluoroscopy

X-ray and fluoroscopy testing of pacemakers similar to the

DR650 Series pacemakers by exposure to diagnostic X-ray or

K
fluoroscopic radiation has not affected those pacemakers.

Assistance

Assistance Information

Medtronic employs highly trained representatives and engineers
located throughout the world to serve you and, upon request, to
provide training to qualified hospital personnel in the use of
Medtronic products. Medtronic also maintains a professional staff to
provide technical consultation to product users. For medical
consultation, Medtronic can often refer product users to outside
medical consultants with appropriate expertise. For more
information, contact your local Medtronic representative or call or
write Medtronic at the appropriate address or telephone number
listed on the back cover.

48

Chapter 3 - Description

Pacing Mode Operations 50

Rate Responsive Pacing 52

Timing Operations 54

Pacing and Sensing Operations 58

Special Therapy Options 65

Description

49

Description

Pacing Mode Operations

A brief description of programmable mode operations is given below.

Warnings :

■

Do not use rate responsive modes in those patients who
cannot tolerate pacing rates above the programmed
Lower Rate.

■

Do not use single chamber atrial modes in patients with
impaired AV nodal conduction because ventricular capture
cannot be assured.

DDDR / DDD Modes

In the presence of sensed atrial events, the ventricle will track the
atrium in both the DDDR and DDD modes. Both chambers are paced
at the sensor-indicated rate (DDDR) or the programmed Lower Rate
(DDD) in the absence of sensed intrinsic events. An atrial sensed
event inhibits atrial pacing and initiates a ventricular pace after the
Sensed AV (SAV) interval. An atrial paced event initiates a ventricular
pace after the Paced AV (PAV) interval. A ventricular sensed event
during either AV interval inhibits the ventricular pace.

DDIR / DDI Modes

Sensed atrial events are not tracked by the ventricle; such events
however, inhibit the scheduled atrial pace. Both chambers are paced
at the sensor-indicated rate (DDIR) or the programmed Lower Rate
(DDI). An atrial paced event initiates a ventricular pace after the
Paced AV (PAV) interval, unless inhibited by a sensed ventricular
event.

DVIR / DVI Modes

Both chambers are paced at the sensor-indicated rate (DVIR) or the
programmed Lower Rate (DVI) in the absence of sensed ventricular
events. An atrial paced event initiates a ventricular pace after the

50

Description

Paced AV (PAV) interval, unless inhibited by a sensed ventricular
event.

VDD Mode

In the presence of sensed atrial events, the ventricle will track the
atrium in the VDD mode. The ventricle is paced at the programmed
Lower Rate in the absence of sensed intrinsic events. A sensed atrial
event initiates a ventricular pace after the Sensed AV (SAV) interval
unless inhibited by a sensed ventricular event. The SAV interval may
delay the ventricular pace at a rate slower than the programmed
Lower Rate. No pacing occurs in the atrium.

VVIR / VDIR, AAIR / ADIR Modes

The ventricle is paced at the sensor-indicated rate (VVIR and VDIR)
in the absence of intrinsic ventricular events. Events in the atrium are
also sensed and recorded for diagnostic purposes (VDIR). The
atrium is paced at the sensor-indicated rate (AAIR and ADIR) in the
absence of intrinsic atrial events. Events in the ventricle are also
sensed and recorded for diagnostic purposes (ADIR).

VVI / VDI, AAI / ADI, VVT / AAT Modes

The ventricle is paced at the programmed Lower Rate (VVI and VDI)
in the absence of intrinsic ventricular events. Events in the atrium are
also sensed and recorded for diagnostic purposes (VDI). The atrium
is paced at the programmed Lower Rate (AAI and ADI) in the
absence of intrinsic atrial events. Events in the ventricle are also
sensed and recorded for diagnostic purposes (ADI).

Sensed ventricular events in the VVT mode trigger pacing pulses.
Sensed atrial events in the AAT mode trigger pacing pulses.

Note: Programmed triggered pacing will not occur faster than
300 ms (200 ppm) from the previous paced event. Temporary
programmed triggered pacing is not limited to 300 ms (200 ppm).

51

Description

DOOR / DOO, VOOR / VOO, AOOR / AOO Asynchronous Modes

The DOOR mode paces the atrium and ventricle sequentially at the
sensor-indicated rate, whereas the DOO mode paces both chambers
at the programmed Lower Rate. The VOOR mode paces the ventricle
at the sensor-indicated rate, whereas the VOO mode paces at the
programmed Lower Rate. The AOOR mode paces the atrium at the
sensor-indicated rate, whereas the AOO mode paces at the
programmed Lower Rate.

ODO / OVO / OAO Diagnostic Modes

The ODO mode senses both intrinsic atrial and ventricular events.
The OVO mode senses only intrinsic ventricular events, whereas the
OAO mode senses only intrinsic atrial events.

Warning: These modes should never be programmed for
pacemaker-dependent patients. For such patients, the programmer’s
“Inhibit” function may be used for brief interruption of outputs.

Rate Responsive Pacing

The KDR650 Series pacemakers use activity-based pacing, which
varies the pacing rate in response to the patient’s detected physical
motion. In rate responsive modes, the pacing rate varies between the
Lower Rate and Upper Sensor Rate limits and is dependent on the
following programmable parameters:

■

Activity Threshold establishes the minimum signal amplitude
above which activity signals are detected by the activity circuit.

■

Activity Acceleration and Deceleration times determine how
quickly the rate will rise and fall as a result of changes in patient
physical activity. Deceleration can also extend the rate fall by
providing up to 20 minutes of rate deceleration based on the
intensity and duration of exercise.

52

Description

Rate response is initialized and DDDR pacing becomes effective
upon completion of Implant Detection.

Rate Profile Optimization

Rate Profile Optimization controls how rapidly and to what level the
sensor-indicated rate increases and decreases within submaximal
and maximal rate ranges:

■

Submaximal rates are moderate pacing rates achieved during
typical daily patient activities. These rates are at or near the
ADL (Activities of Daily Living) Rate.

■

Maximal rates are rates at or near the Upper Sensor Rate
achieved during vigorous activities.

Rate response for rates below the submaximal rate range (i.e., at or
near the Lower Rate) are also controlled by Optimization.

Rate response function is optimized in the submaximal and maximal
rate ranges by a daily comparison of data in two rate profiles:

■

Sensor rate profile is an actual rate distribution of the patient’s
averaged sensor-indicated rates.

■

Target Rate Profile is a programmable rate distribution of the
patient’s desired rates. The ADL Response and Exertion
Response parameters define the time spent pacing in the
submaximal and maximal ranges, respectively.

Once each day, the pacemaker evaluates the percent of time spent
pacing in both the submaximal and maximal rate ranges by
comparing the sensor rate profile against the target rate profile. From
this comparison, the pacemaker automatically adjusts rate response
in both rate ranges.

53

Description

Timing Operations

A-A Timing and Mean Atrial Rate

KDR650 Series pacemakers use A-A timing, that is, in all dual
chamber modes that pace the atrium, the pacemaker mimics sinus
rhythm by timing from atrial event to atrial event. The pacemaker
keeps a running average of all A-A intervals (except those starting
with an atrial sense or atrial refractory sense and ending with an atrial
pace) which is called the Mean Atrial Rate (MAR). The Mean Atrial
Rate is used by the pacemaker in Rate Adaptive AV operation.

Rates

The KDR650 Series pacemakers have four rates that determine the
patient’s pacing rate.

■

The programmable Lower Rate is the minimum pacing rate for
a given mode.

■

The programmable Upper Tracking Rate is the maximum
ventricular rate at which the atrium is tracked in the DDDR,
DDD, and VDD mode.

■

ADL Rate (Activities of Daily Living Rate) is the average target
rate that the patient’s heart rate is expected to reach during
moderate exercise.

■

Upper Sensor Rate provides the upper limit for the
sensor-driven rate during physical activity, particularly during
vigorous exercise.

AV Intervals

The pacemaker has separately programmable paced and sensed AV
intervals that determine the duration between an atrial event and the
delivery of a ventricular stimulus in dual chamber modes.

■

The programmable Paced AV (PAV) interval defines the
duration from paced atrial events to paced ventricular events.

54

Description

The ventricle is paced after the PAV expires unless inhibited by
a sensed ventricular event.

Note: PAV duration may differ from the programmed setting due
to Mode Switch, Rate Adaptive AV, Ventricular Safety Pacing,
Non-Competitive Atrial Pacing or Capture Management
operation.

■

The programmable Sensed AV (SAV) interval defines the
duration from sensed atrial events to paced ventricular events.
The ventricle is paced after the SAV expires unless inhibited by
a sensed ventricular event. SAV maintains 1:1 AV tracking up
to the Upper Tracking Rate (UTR) or the total atrial refractory
period (which is the sum of the SAV and the PVARP).

Note: SAV duration may differ from the programmed setting
due to Mode Switch, Rate Adaptive AV, or Capture
Management operation or may be extended as the result of
Wenckebach operation if the intrinsic atrial rate exceeds
the UTR.

Rate Adaptive AV

The programmable On or Off Rate Adaptive AV (RAAV) feature
provides rate-variable PAV and SAV intervals. The variable PAV
shortens or lengthens to the sensor-indicated rate, whereas the
variable SAV shortens or lengthens to the Mean Atrial Rate. The
variable SAV promotes 1:1 AV tracking to sensed atrial events at
higher rates. Several programmable parameters define RAAV
operation.

■

Start Rate defines the rate at which RAAV operation begins.

■

Stop Rate defines the rate above which the PAV and SAV
intervals stop shortening and remain at the minimum AV
interval.

■

Max Offset defines the maximum amount of time by which the
PAV and SAV intervals can be shortened.

55

Description

As the sensor-indicated rate increases above the Start Rate, the PAV
gradually shortens until the programmed Max Offset is reached at the
Stop Rate. As the Mean Atrial Rate increases above the Start Rate,
the SAV gradually shortens until the programmed Max Offset is
reached at the Stop Rate.

The approximate interval difference between the programmed PAV
and SAV is maintained throughout the rate range when RAAV is
active. The pacemaker operates at the programmed PAV and SAV at
rates below the programmed Start Rate.

Notes:

■

The 2:1 block rate increases to a higher rate as the SAV
component of the TARP shortens.

■

The sensing window after the PVARP lengthens as the PAV
shortens at higher rates.

Upper Rate Behaviors (2:1 Block Rate, Wenckebach)

The 2:1 block rate occurs when every other atrial event falls within the
PVARP. Such refractory sensed events do not initiate an SAV and,
thus, are not synchronized to a ventricular paced event, thereby
producing a 2:1 block rate. If the 2:1 block rate exceeds the
programmed Upper Tracking Rate, the SAV is extended to limit the
ventricular rate at the Upper Tracking Rate, thereby producing
pacemaker Wenckebach operation.

Refractory and Blanking Periods

The pacemaker has several refractory periods to avoid inappropriate
restarting of certain timing intervals.

■

The programmable Post-Ventricular Atrial Refractory Period
(PVARP) prevents tracking of retrograde P waves. In the DDIR
and DDI modes, PVARP prevents atrial inhibition from
retrograde P waves. The PVARP occurs after paced, sensed,

56

Description

and refractory sensed ventricular events and is set to at least
400 ms after a pacemaker-defined PVC.

The first portion of the PVARP is a programmable Post­Ventricular Atrial Blanking period which disables atrial sensing
after paced, sensed, and refractory sensed ventricular events.

– The programmable sensor-varied PVARP protects against

PMTs at lower sensor-indicated rates by lengthening the
PVARP and provides a higher 2:1 block rate at higher
sensor-indicated rates by shortening the PVARP.
Sensor-varied PVARP is based on the sensor-indicated
pacing rate and varies from approximately 400 ms at the
lower rate to no less than the Post-Ventricular Atrial
Blanking period at higher sensor rates.

■

The programmable Ventricular Refractory Period (VRP)
prevents sensing of T-waves or PVCs. The VRP occurs after
paced, sensed, and refractory sensed ventricular events in
dual chamber and ventricular single chamber modes.

The first portion of the VRP is a nonprogrammable Ventricular
Blanking period in which ventricular sensing is disabled after
paced, sensed, and refractory sensed ventricular events. The
Ventricular Blanking period varies dynamically from
50 to 100 ms based on the strength and duration of the
ventricular event.

■

The programmable Ventricular Blanking period disables
ventricular sensing in dual chamber modes to prevent potential
crosstalk from paced atrial events.

■

The programmable Atrial Refractory Period (ARP) prevents
atrial inhibition due to sensed far-field R waves or noise. The
ARP occurs after paced, sensed, and refractory sensed atrial
events in single chamber atrial modes.

The first portion of the ARP is a programmable Atrial Blanking
period that disables atrial sensing after paced, sensed, and
refractory sensed atrial events.

57

Description

■

The first portion of the PAV and SAV intervals is a
nonprogrammable Atrial Blanking period in which atrial
sensing cannot take place after paced or sensed atrial events.
The Atrial Blanking period varies dynamically from 50 to
100 ms based on the strength and duration of the atrial event.

Pacing and Sensing Operations

Polarity

Unipolar polarity uses the lead tip as the active electrode and the
pacemaker case as the common electrode. Bipolar polarity uses the
lead tip as the active electrode and the lead ring as the common
electrode.

With the bipolar Model K
sensing polarities are automatically or manually programmable, and
in dual chamber pacemakers polarity is independently
programmable for the atrial and ventricular channels. The Model

DR656 provides unipolar pacing and sensing only.

K

Automatic Polarity Configuration

With bipolar pacemakers, polarity settings are selected automatically
during the pacemaker’s 30-minute Implant Detection period that
begins at lead insertion. During Implant Detection, with either bipolar
or unipolar leads implanted, and with the Configure or Adaptive
parameter under Lead Monitor active, the pacemaker continuously
measures impedance as follows:

■

The pacemaker issues a bipolar pace and immediately checks
the pace for high impedance.

– If the pace is within range, it is considered an acceptable

bipolar pace.

– If high impedance is found, the pacemaker immediately

follows the bipolar pace with a backup unipolar pace.

DR651 and KDR653 pacemakers, pacing and

58

Description

■

If a unipolar backup pace is issued, the pacemaker checks it
for high impedance.

– If the pace is within range, it is considered an acceptable

unipolar pace.

– If high impedance is found, the pacemaker assumes a lead

is not attached and restarts Implant Detection.

Note: During polarity configuration, the pacemaker also
checks for low impedance paces but does not follow them with
unipolar backup paces. To avoid possible loss of capture due
to continuous low impedance pacing, the pacemaker sets
unipolar polarity when 3 of 16 paces are detected as low
impedance during the first phase of configuration (described
below).

Warning: If the Implant Detection feature identifies a bipolar,
high-impedance path, backup unipolar pacing will be
delivered. This may be inappropriate for patients with an
implantable defibrillator (ICD). See “Notes” on page 3-14.

Polarity configuration for bipolar pacemakers takes place in two
phases:

■

Initial Configuration Phase – Five minutes after lead
connection, if a high impedance unipolar pace has not reset
Implant Detection, the pacemaker issues three asynchronous
paces at magnet rate and determines if they are bipolar or
unipolar.

– Two of three paces must be bipolar for initial pacing and

sensing polarities to be determined bipolar for the
Confirmation Phase.

– Two of three paces must be unipolar for initial pacing and

sensing polarities to be set to unipolar and remain unipolar
during and after Implant Detection.

■

Confirmation Phase – If bipolar polarity is determined at five
minutes, the remaining 25 minutes of Implant Detection is used
to confirm bipolar polarity.

59

Description

– The pacemaker continues to monitor each pace as

described above, providing backup unipolar paces for high
impedance bipolar paces.

– The pacemaker checks for a programmed number of out-

of-range (high or low impedance) paces that indicate
bipolar pacing is in jeopardy.

– The pacemaker confirms bipolar pacing and sensing

polarity at the end of 25 minutes by examining three
asynchronous paces as described above for the Initial
Configuration Phase.

Note: If a prevalence of out-of-range bipolar paces is detected
during the Confirmation Phase, the pacemaker reconfigures
pacing and sensing polarities to unipolar and the
asynchronous paces are not delivered.

Warning: When implanting a Model K

DR653 pacemaker, ensure that

both the tip and ring setscrews are properly engaged and all
electrical contacts are sealed in order to prevent possible electrical
leakage between the tip and ring contacts. Such leakage may cause
the pacemaker to falsely identify a unipolar lead as bipolar, resulting
in a loss of output. For the same reason, ensure that electrical
contacts are sealed when using lead extenders or adaptors with all
bipolar models.

Notes:

■

During Implant Detection, the unipolar-only Model KDR656
pacemaker examines unipolar pacing impedance to determine
lead connection.

■

When implanting a bipolar pacemaker in a patient with an
implantable defibrillator, the physician has the option to
manually program polarities to avoid the possible occurrence
of unipolar backup paces during Implant Detection.

60

Description

Manually Programming Polarity

Pacing and Sensing Polarities for the Models KDR651 and KDR653
can also be manually programmed. However, the Configure selection
under Lead Monitor, which controls automatic configuration, must be
“turned off” by programming the Monitor Only selection instead.

When pacing and/or sensing polarity is manually programmed from
unipolar to bipolar, the pacemaker verifies whether a functioning
bipolar lead is connected by measuring lead impedance. If lead
impedance is outside the accepted programmed impedance range
for bipolar polarity (between 200 and 4000 ohms), the lead is
assumed to be unipolar and pacing and/or sensing polarity remains
set to unipolar.

Warning: If the clinician overrides the bipolar lead verification and
programs bipolar polarity when a unipolar lead is connected to the
pacemaker, no pacing output results.

Lead Monitor

The Lead Monitor feature enables the pacemaker to monitor lead
integrity and adapt bipolar pacing and sensing to unipolar when
bipolar lead integrity is in doubt. It also controls automatic
configuration of lead polarities at implant. Lead Monitor is available in
all pacing modes.

The Lead Monitor feature monitors lead integrity by looking for high
and low impedance on each pace. The Atrial and Ventricular Lead
Monitor can be programmed to operate as follows:

■

Configure – provides automatic polarity configuration of bipolar
pacemakers (bipolar pacemakers are shipped in Configure).

■

Adaptive
– monitors bipolar paces and provides backup unipolar

paces when impedance is high

– switches pacing and sensing polarities from bipolar to

unipolar when a prevalence of out-of-range (high and low
impedance) paces is detected

61

Description

– provides automatic polarity configuration if the pacemaker

is programmed to Adaptive prior to implant

■

Monitor Only – monitors unipolar and bipolar paces to
determine if they are out of range (high and low impedance).
Unipolar-only Model K

DR656 is shipped in and only

programmable to Monitor Only.

When Lead Monitor is set to Adaptive or Monitor Only, and the
pacemaker determines a lead is out of range, the pacemaker issues
a status warning that appears on the programmer screen at the next
interrogation. However, a status warning is not issued at any time
during the configuration process.

After automatic polarity configuration is complete, Lead Monitor is
automatically set to Monitor Only for bipolar and unipolar
configurations. If, however, the Adaptive setting was programmed
prior to implant, bipolar configurations are set to Adaptive, but
unipolar configurations are set to Monitor Only.

Warning: Lead Monitor should not be programmed to Adaptive for
patients with implantable defibrillators. When there is a prevalence of
out-of-range lead impedance paces detected, the monitor
automatically reprograms the selected lead(s) to unipolar polarity.
Pacing in the unipolar configuration may cause the defibrillator either
to provoke inappropriate therapy or to withhold appropriate therapy.

Caution: If the Lead Monitor detects out-of-range lead impedance,
investigate lead integrity more thoroughly.

Sensitivity

Sensitivity determines the minimum intracardiac signal that the
pacemaker can detect when intrinsic atrial and ventricular events
occur. With K
or manually programmable.

Sensing Assurance, the pacemaker’s automatic sensing feature,
adjusts sensitivities within defined limits. At the completion of Implant
Detection, the pacemaker enables Sensing Assurance and begins

DR650 Series pacemakers, sensitivity is automatically

62

Description

continual monitoring of the peak amplitude of sensed signals. In
response to monitoring, it automatically increases or decreases
Sensitivity to maintain an adequate sensing margin with respect to
the patient’s sensed P and R waves.

During provocative myopotential testing of the Medtronic Kappa 700
Series pacemakers having Sensing Assurance On, 56% (28/50) of
patients experienced atrial oversensing while 7.3% (4/55)
experienced ventricular oversensing. The atrial oversensing rate is
comparable to that experienced by Medtronic’s Thera devices which
had an atrial oversensing rate of 52.4% (75/143) during provocative
testing. The ventricular oversensing rate of Medtronic Kappa 700
Series pacemakers compared favorably to the ventricular
oversensing rate experienced by Medtronic Thera pacemakers –

44.1% (63/143).

For guidelines regarding manually programming Sensitivity settings,
refer to “Parameter Programming at Implant” on page 40.

Atrial and Ventricular sensitivities are separately programmable.
They can also be programmed on a temporary basis.

Note: Atrial Sensitivity with unipolar sensing polarity is restricted to

0.5 mV to limit oversensing of muscle noise or electromagnetic
interference.

Pacing Output

Amplitude and Pulse Width determine the pacing pulse strength
necessary to capture the atrium and ventricle. Amplitude and Pulse
Width are programmable for the atrial and ventricular channels.
Amplitude and Pulse Width can also be programmed on a temporary
basis. Refer to “Parameter Programming at Implant” on page 40 for
pacing output guidelines.

63

Description

Capture Management

The Capture Management feature provides automatic monitoring of
ventricular pacing thresholds and automatic adjustment of Amplitude
and Pulse Width to maintain capture.

When Capture Management is programmed to Monitor Only, the
pacemaker periodically causes paces to be delivered (affecting
pacemaker timing temporarily if necessary). The pacemaker then
monitors the paces by changing first amplitude and then pulse width
to find two points that lie on the strength duration curve that define
the boundary between settings that capture and those that do not.
How often the pacemaker performs this pacing threshold search is
determined by the programmable Capture Test Frequency
parameter. This parameter determines how often the pacing
threshold search will be initiated and provides for retry if the test
is delayed.

When Capture Management is programmed to Adaptive, the
pacemaker responds to monitoring by adapting ventricular amplitude
and pulse width using the following programmable parameters:

■

Amplitude Margin and Pulse Width Margin – the pacemaker­determined threshold multiplied by the selected safety factor.

■

Minimum Adapted Amplitude and Minimum Adapted Pulse
Width – the lowest Amplitude and Pulse Width values that the
pacemaker can suggest for programming after a pacing
threshold search has been performed.

■

Acute Phase Days Remaining – time in days when the
pacemaker will never suggest the use of output settings less
than the operating Amplitude and Pulse Width values. This
parameter is used during the lead maturation period.

Capture Management becomes operational automatically when
Implant Detection is completed.

Warning: Capture Management will not program ventricular outputs
above 5.0 V or 1.0 ms. If the patient needs a pacing output higher
than 5.0 V or 1.0 ms, program Amplitude and Pulse Width manually.

64

Description

Note: In the event of partial or complete lead dislodgment, Capture
Management may not prevent loss of capture.

Special Therapy Options

The pacemaker has several therapy features for managing atrial and
ventricular arrhythmias and other pacing operations. A brief
description of these features is given below.

Mode Switch

Mode Switch is a programmable On or Off feature designed to
prevent tracking of paroxysmal atrial tachycardias in the DDDR,
DDD, and VDD modes. Whenever a rapid atrial rhythm is detected,
the pacemaker switches from an atrial tracking mode to a non-atrial
tracking mode until the atrial tachycardia ceases. Mode switching
occurs as follows:

Atrial Tracking Mode Non-Atrial Tracking Mode

DDDR DDIR

DDD DDIR

VDD VDIR

In determining when to mode switch, the pacemaker continuously
monitors A-A intervals for a rapid atrial rate. When it determines that
the atrial rate equals or exceeds the programmed Detect Rate, the
rate at which pacemaker-defined atrial tachycardia starts, the
pacemaker switches mode and gradually changes the ventricular
rate to the sensor-indicated rate. When seven A-A intervals occur
below the Upper Tracking Rate, or five consecutive atrial paces
occur, the pacemaker switches back to the programmed atrial
tracking mode.-

→
←

→
←

→
←

65

Description

In monitoring the atrial rate for tachycardias, the pacemaker
searches for:

■

any four of the last seven A-A intervals that are shorter than the
programmed Detect Rate interval, and

■

eight consecutive A-A intervals that measure less than two
times the total atrial blanking period (AV interval + PVAB) and
less than two times the Detect Rate interval. If they are found,
the pacemaker extends the PVARP for one beat to expose the
blanked atrial flutter that may be occurring. This search occurs
if the Blanked Flutter Search parameter is On.

Note: Mode Switch is not recommended for patients with chronic
refractory atrial tachyarrhythmias (i.e., atrial tachycardia, atrial
fibrillation, atrial flutter).

Non-Competitive Atrial Pacing

Non-Competitive Atrial Pacing (NCAP) is a programmable On or Off
feature in the DDDR and DDD modes. NCAP prevents an atrial pace
from falling within the atrium’s relative refractory period, thereby
preventing a potential atrial tachycardia. A refractory sensed atrial
event within the PVARP starts a 300-ms NCAP period during which
no atrial pacing may occur. The scheduled atrial pace is delayed until
the NCAP period expires, thus preventing pacing within the atrium’s
relative refractory period. The Paced AV following NCAP operation
may be shortened to a minimum of 30 ms to maintain a stable
ventricular rate.

Note: Even when NCAP is programmed Off, NCAP operation is
invoked automatically in the DDDR mode for one cycle when PVC
Response or PMT Intervention operations occur.

66

Description

PMT Intervention

Pacemaker-Mediated Tachycardia (PMT) Intervention is a
programmable On or Off feature that provides automatic detection
and interruption of pacemaker-defined PMTs. The pacemaker
detects a PMT episode as eight consecutive ventricular pace-to-atrial
sense events with VA intervals less than 400 ms. In addition, the
pacemaker corroborates the episode as a PMT if, on the eighth
consecutive pace, the Sensor Rate is at or below the ADL rate. When
an episode is detected and corroborated, the pacemaker intervenes
by forcing a 400-ms PVARP for one pacing cycle. Extending the
PVARP ensures that the next sensed atrial event within 400 ms will
be refractory, thus interrupting atrial tracking for one cycle, which may
stop the PMT.

Note: A sinus tachycardia could cause a feature intervention,
resulting in a single P wave falling in the PVARP and therefore not
being tracked by the pacemaker.

After intervention occurs, PMT detection is automatically suspended
for 90 seconds to prevent unnecessary intervention for fast intrinsic
atrial rates.

Caution: Even with the feature turned On, PMTs may require clinical
intervention such as pacemaker reprogramming, magnet application,
drug therapy, or lead evaluation.

PVC Response

Premature Ventricular Contraction (PVC) Response is a
programmable On or Off feature that prevents tracking of retrograde
P waves generated by PVCs in the DDDR, DDD, and VDD modes.
PVC Response prevents inhibition of atrial pacing resulting from
retrograde P waves generated by PVCs in the DDIR and DDI modes.
Any ventricular event-to-ventricular refractory or nonrefractory sense
event with no intervening atrial event starts a minimum PVARP of 400
ms. A minimum PVARP of 400 ms causes retrograde P waves to be
sensed as refractory events, thereby preventing retrograde P waves

67

Description

from starting an SAV interval which could result in a PMT. Note that
an SAV interval is not started in the DDIR and DDI modes.

Ventricular Safety Pacing

Ventricular Safety Pacing (VSP) is a programmable On or Off feature
that prevents ventricular asystole due to inappropriate inhibition of
ventricular pacing by crosstalk or ventricular oversensing. A sensed
ventricular event within 110 ms after an atrial pacing pulse results in
a ventricular pacing pulse at 110 ms or the programmed or rate
adaptive PAV interval, whichever expires first. If the sensed event
was, in fact, a ventricular depolarization, the ventricular pacing pulse
at 110 ms falls harmlessly into the absolute refractory period of the
ventricle.

Warning: VSP should always be programmed On for pacemaker­dependent patients.

Sleep Function

Sleep Function is a programmable On or Off feature that reduces the
paced rhythm during sleep. It replaces the programmed Lower Rate
with a slower Sleep Rate during a programmable sleep period. At the
programmed Bed Time, the pacemaker gradually lowers the
operating lower rate from the programmed Lower Rate to the
programmed Sleep Rate over a 30 minute period. The Sleep Rate
becomes the operating lower rate until the programmed Wake Time
occurs, when the pacemaker gradually raises the operating lower
rate from the Sleep Rate to the Lower Rate over a 30 minute period.

Note: For rate responsive modes, the Sleep Rate becomes the
minimum rate during the sleep period. However, in the presence of
sensor-detected activity, the sensor-indicated rate overrides the
Sleep Rate.

68

Description

Single Chamber Hysteresis

Single Chamber Hysteresis allows tracking of an appropriate intrinsic
rhythm below the Lower Rate during extended periods of inactivity
such as sleep. When a nonrefractory sensed event occurs, sensed
events that follow are allowed to occur below the programmed Lower
Rate to the programmed Hysteresis Rate. As long as the intrinsic rate
is above the Hysteresis Rate, pacing is inhibited. When the intrinsic
rate drops to the Hysteresis Rate, escape pacing results and the
programmed Lower Rate returns as the operating lower rate until the
next nonrefractory sensed event occurs.

69

Chapter 4 - Pacemaker Follow-up

Pacemaker Telemetry 72

Other Operations 75

Diagnostics 79

General Recommendations 80

Pacemaker Follow-up

71

Pacemaker Follow-up

Pacemaker Telemetry

Pacemaker telemetry is established by placing the programming
head over the implant site and moving the head along the axis shown
in Figure 6 until the head lights indicate telemetry is possible.
Pacemaker telemetry can be used for routine monitoring. A brief
description of the types of telemetry is given below.

Axis

Figure 6. Positioning the Programming Head

Parameter Summary

Upon interrogation by the programmer, the pacemaker telemeters
the programmed parameter settings along with battery status and
device identification.

Note: The parameters may change due to a full or partial electrical
reset, elective replacement indication, Rate Profile Optimization,
automatic Sensitivity, Capture Management, or Lead Monitor
operation. See the appropriate topic for more information.

Battery and Lead Information

The pacemaker provides Battery and Lead Information for both
measured and calculated values of the pacing output pulse(s), the
lead(s), and the battery. The pacemaker’s Battery and Lead
Information is accessed via the programmer.

72

Pacemaker Follow-up

Telemetry Markers (Extended Markers)

Telemetry markers depict cardiac events that are useful in evaluating
pacemaker operations.

■

Standard Markers (Marker Channel Telemetry) annotate
pacemaker paced, sensed, and refractory sensed events in
any mode.

■

Therapy Trace Markers provide depictions of therapy
interventions that alter timing intervals.

Electrogram (EGM)

The Electrogram (EGM) is a real-time intracardiac waveform
detected by the atrial or ventricular lead. Atrial and ventricular
waveforms can be displayed simultaneously with Dual EGM
(simultaneous display of the independent channels) or Summed
EGM (the electrical summation of both channels). The waveform(s)
is accompanied by standard Marker Channel telemetry annotation.

Warning: An EGM of the patient’s intrinsic activity should be
obtained with care since the patient is without pacing support when
using the programmer’s inhibit function.

Notes:

■

The simulated pacing pulses on the EGM should not be
interpreted as representing the actual timing or amplitude of
paced events. Use an ECG to determine such events.

■

Intracardiac amplitudes measured on the EGM should not be
used to assess the adequacy of the programmed Sensitivity
setting. Use the sensing test instead.

73

Pacemaker Follow-up

Transtelephonic Monitor

The Transtelephonic Monitor is a programmable On or Off feature
intended for use with remote pacemaker monitoring services. When
the Transtelephonic Monitor is programmed On, the Threshold
Margin Test is delayed for five seconds upon magnet application to
enhance communication with transtelephonic equipment. If the
pacing polarity is programmed to bipolar, it is temporarily set to
unipolar to provide improved ECG artifact detection for the remote
monitoring equipment. (The programmed polarity is restored when
the magnet is removed.) When Transtelephonic Monitor is
programmed Off, the Threshold Margin Test is not delayed upon
magnet application, and conventional transtelephonic monitoring
can occur.

Warning: Programming Transtelephonic Monitor On is
contraindicated for patients with implantable defibrillators. When it is
programmed On, the pacing polarity is temporarily set to unipolar
when the magnet is applied. Pacing in the unipolar configuration may
cause the defibrillator either to provoke inappropriate therapy or to
withhold appropriate therapy.

Extended Telemetry

Extended Telemetry provides frequent patient monitoring in the
programmed mode. When Extended Telemetry is programmed On,
the pacemaker automatically transmits the programmed telemetry
type (i.e., Electrogram, Marker Channel telemetry) when the
programmer head or monitoring receiver (with or without a magnet)
is positioned over the pacemaker. Extended Telemetry is
automatically programmed Off after 48 hours or can be programmed
Off via the programmer.

74

Pacemaker Follow-up

Other Operations

Magnet Operation

Magnet operation includes an initial capture safety margin test, an
automated self test, and magnet mode operation with telemetry:

■

The Threshold Margin Test (TMT) provides a check for loss of
capture. It is performed at 100 ppm with pulse amplitudes
reduced by 20% on the third pulse.

Warning: Loss of capture during TMT may indicate that the
stimulation threshold safety margin is inadequate. Perform a
pacing threshold test and reprogram outputs to establish a 2:1
voltage safety margin, if necessary.

■

The Fully Automated Self Test (FAST) is a pattern of pacing
pulses that indicates either of the following events has
occurred:

– Lead Monitor has detected an out-of-range lead, and, if

programmed to Adaptive, has switched polarities from
bipolar to unipolar.

– Capture Management has measured unusually high

ventricular thresholds.

Beginning on the cycle following TMT, the pacemaker delivers
two pacing pulses at 85 ppm followed by two pulses at 65 ppm
and then repeats the same sequence once again.

■

Magnet Mode forces the pacemaker’s programmed operation
to an asynchronous mode (DOO in dual chamber
configurations, VOO in the VDD mode, and VOO/AOO in
single chamber configurations). Magnet Mode rate is 85 ppm
for all of the above modes. However, the rate is 65 ppm if an
electrical reset occurs or the elective replacement indicator
is set.

75

Pacemaker Follow-up

Magnet Operation Using the Transtelephonic Magnet

When a transtelephonic magnet is placed over the pacemaker, a
TMT is automatically initiated. A FAST, if programmed On,
immediately follows the TMT if any of the events mentioned above
that initiate the test have occurred. When the FAST (or TMT when a
FAST is not initiated) is completed, pacing is forced to Magnet Mode
operation until the magnet is removed.

Magnet Operation Using the Programming Head

The programming head does not initiate a TMT when placed over the
pacemaker. The clinician must perform a Magnet Test in order to
obtain a TMT. A FAST, if programmed On, will follow the TMT if
initiated by any of the events described above. When the FAST (or
TMT when a FAST is not initiated) is completed, pacing is forced to
Magnet Mode operation until the Magnet Test is terminated or the
programming head is removed.

FAST Reporting Using the Remote Assistant

With the patient-activated hand-held Remote Assistant, the FAST
results indicating a lead or threshold problem are reported by two
beeps in a low tone, and a yellow light appears on the underside of
the activator. When no problems exist, the FAST results are reported
by three beeps, and a green light appears instead.

FAST with the Remote Assistant also reports if the ERI has been set
or an electrical reset has occurred (indicated by two beeps and a
yellow light from the activator).

Temporary Parameters

Several pacemaker parameters can be programmed temporarily
during a patient session. These include: Mode, Rate, Amplitude,
Pulse Width, and Sensitivity, and AV intervals.

76

Pacemaker Follow-up

Electrical Reset

A partial Electrical Reset can occur when the pacemaker is exposed
to cold temperatures, electrocautery, internal or external
defibrillation. Under these conditions, the pacemaker resumes
pacing at the previously programmed mode and preserves many of
the primary pacing parameter settings in operation prior to the partial
reset. See “Electrical Reset Parameter Settings” on page 89 for a
complete list of the preserved settings as well as full Electrical Reset
settings.

If the temperature or electrical disturbance is severe enough, the
pacemaker can reset to full Electrical Reset settings, in which case
the pacemaker reverts to VVI mode at a pacing rate of 65 ppm and
restarts Implant Detection. To restore the pacemaker to its previous
mode and pacing operations, it must be reset and manually
reprogrammed via the programmer.

Note: If after a reset a message appears on the programmer screen
or printout indicating the Date/Time memory has been altered,
contact your Medtronic representative for further information.

Elective Replacement Indicator

The Elective Replacement Indicator (ERI) forewarns when the
battery is nearing depletion. When the pacemaker detects that the
battery voltage has dropped below 2.59 V, the pacemaker sets the
ERI status and reverts to VVI operation at a rate of 65 ppm. Pacing

is maintained, in VVI mode, even in pacemakers previously
programmed to the AAIR, ADIR, AAI, ADI, AAT, AOOR, or
AOO mode.

Caution: When ERI is set and verified, the pacemaker must be

replaced within three months.

High-rate pacing over several years, or with the battery partially
depleted, may trigger the ERI prematurely.

Continuous pacing at high rates (i.e., greater than 100 ppm) and high
output settings (i.e., pulse widths greater than 1.0 ms and/or

77

Pacemaker Follow-up

amplitudes greater than 5.0 V) may cause the battery to deplete
rapidly and set ERI. While operating at ERI, the battery voltage may
rise above 2.59 V, allowing the pacemaker to be reset and
reprogrammed.

Before and after the use of high-rate pacing, the clinician should
interrogate the pacemaker to determine the battery status and ERI
condition.

Emergency Pacing

Emergency pacing provides VVI pacing at high output settings in
emergency situations for pacemaker-dependent patients. See
“Electrical Reset Parameter Settings” on page 89.

Rate Limit

In the event of a single component failure, the absolute rate limit for
atrial and ventricular rates are held independently to 200 ppm. Rate
limit is automatically overridden in temporary single chamber modes
for high rate pacing.

78

Pacemaker Follow-up

Diagnostics

The pacemaker has automatic data summary diagnostics, some of
which have an accompanying clinician-selected diagnostic to collect
further detailed data. At the completion of Implant Detection, the
pacemaker enables diagnostic collection.

Automatic Diagnostics / Clinician-Selected Diagnostics

■

Heart Rate Histograms. Automatically collect short and long
term heart rate and percent-paced data for the atrium and
ventricle.

■

AV Conduction Histogram. Automatically collects short and
long term AV conduction sequences.

■

Sensor Indicated Rate Profile. Automatically collects sensor
rate data.

■

Atrial and Ventricular High Rate Episodes. Automatically
collect basic data on atrial and ventricular high rates and,
optionally, clinician-selected detailed data of atrial, ventricular,
or summed electrograms with a rate trend.

■

Lead Diagnostics. Chronic Lead Impedance Trend
automatically collects long-term chronic lead impedance data.
The automatic Lead Monitor Counters present the impedance
status of every beat. Chronic lead impedance data is collected
in all pacing modes except for triggered pacing modes (AAT
and VVT). This data is not collected in non-pacing modes
(OAO, OVO, and ODO).

■

Sensitivity Trend. Automatically collects the minimum and
maximum sensitivities used to operate automatic sensitivity.

■

Capture Management Trend. Automatically collects
information about the range of ventricular thresholds and
outputs over the life of the device.

79

Pacemaker Follow-up

■

Mode Switch Episodes. Automatically collect basic data on
mode switch episodes, or optionally, clinician-selected
electrogram with a rate trend.

■

Custom Rate Trend. Clinician-selected collection of heart rate
and percent-paced trends over a beat-to-beat 1-hour or
24-hour period.

General Recommendations

During the first few months after receiving a new pacing system the
patient may require close monitoring. In the U.S.A., the physician
may wish to use the individual state’s or Medicare’s maximum
frequency table for dual chamber pacemakers under Guideline I,
i.e., every two months from the second month through three years
post-implant, and monthly thereafter (Ref. Carriers Manual, Part 3,
Claims Process, Transmittal No. 1051, or a later publication, if
available). Note that Guideline I applies to those pacing systems
(i.e., the pacemaker and the lead used) for which 5 years of clinical
data are not yet available.

80

Pacemaker Specifications

Pacemaker Specifications

Lead Requirements, Compatibility 82

Radiopaque Identification 83

Emergency Parameter Settings 84

Shipping and Nominal Parameter Settings 85

Electrical Reset Parameter Settings 89

Elective Replacement Indicator 93

Magnet Mode Conditions 93

Longevity Projections 94

Programmable Parameters 96

Nonprogrammable Parameters 103

Temporary Parameters 104

Telemetry Markers 105

Electrograms 105

Automatic Diagnostics 105

Clinician-Selected Diagnostics 106

Patient Information 106

Battery and Lead Telemetered Information 107

Battery Parameters 108

Mechanical Dimensions 108

81

Pacemaker Specifications

Lead Requirements, Compatibility

The chart below lists the available models by polarity type with the
required lead for proper operation. Refer to “Connecting Leads to the
Pacemaker” on page 32.

Models Polarity Primary Leads

K

DR651 Bipolar/Unipolar IS-1

KDR653 Bipolar/Unipolar Low-profile 3.2 mm bipolar or IS-1a BI

K

DR656 Unipolar Unipolar 5 or 6 mm

a

IS-1 refers to an International Connector Standard (see Document No. ISO 5841-3;

1992) whereby pulse generators and leads so designated are assured of meeting the
electrical and mechanical parameters specified in the IS-1 International Standard.

a

BI

82

Pacemaker Specifications

Radiopaque Identification

Listed below are the pacemaker’s radiopaque identifications, which
are used to identify the pacemaker with fluoroscopy. An X-ray
showing the location of the radiopaque for Model K
Figure 7.

Models Radiopaque

DR651 PLJ

K

K

DR653 PLK

K

DR656 PLL

PLJ

Figure 7. Model KDR651 X-Ray

DR651 is given in

83

Pacemaker Specifications

Emergency Parameter Settings

Listed below in Table 4 are the pacemaker’s emergency parameter
settings.

Table 4. Emergency Settings

Mode VVI

Pacing Rate 70 ppm

Ventricular

Amplitude 7.5 V

Pulse Width 1.5 ms

Sensitivity 2.8 mV

Pacing Polarity Unipolar

Sensing Polarity Unipolar

Lead Monitor Monitor Only

Capture Management Off

Ventricular Refractory Period 330 ms

Single Chamber Hysteresis Off

84

Pacemaker Specifications

Shipping and Nominal Parameter Settings

Listed below in Table 5 are the pacemaker’s shipping and nominal
parameter settings.

Note: “Adaptive” indicates that the parameter value is adapted
during operation. “Unchanged” indicates that the parameter setting is
unchanged by nominal programming.

Table 5. Shipping and Nominal Settings

Parameter Shipping Medtronic

Mode DDDR

Mode Switch On On

Detect Rate 175 bpm 175 bpm

Detect Duration No Delay No Delay

Blanked Flutter Search On On

Lower Rate 60 ppm 60 ppm

Upper Tracking Rate 120 ppm 120 ppm

Upper Sensor Rate 120 ppm 120 ppm

ADL Rate 95 ppm 95 ppm

Rate Profile Optimization On

ADL Response 3-Mod. Active 3-Mod. Active

Exertion Response 3-Mod. Frequent 3-Mod. Frequent

Activity Threshold Med. Low Unchanged

Activity Acceleration 30 sec Unchanged

Activity Deceleration Exercise Unchanged

a

a

Nominal

DDDR

Unchanged

85

Pacemaker Specifications

Tab le 5. Shipping and Nominal Settings (Continued)

Parameter Shipping Medtronic

Atrial Lead

Amplitude 3.5 V 3.5 V

Pulse Width 0.4 ms 0.4 ms

Sensitivity 0.5 mV (Adaptive

Sensing Assurance On

Pace Polarity Configure

Sense Polarity Configure

Lead Monitor Configure

a

a

or

c

Unipolar

Unipolar

a

or

c

d

or

Monitor Only

c

Notify if < 200 ohms Unchanged

Notify if > 4000 ohms 4000 ohms

Monitor Sensitivity 8 8

Nominal

a

) 0.5 mVb (Adaptive)

On

Unchanged

Unchanged

Unchanged

Ventricular Lead

Amplitude 3.5 V 3.5 V

Pulse Width 0.4 ms 0.4 ms

b

b

Sensitivity 2.8 mV (Adaptive) 2.8 mVb (Adaptive)

Sensing Assurance On On

Pace Polarity Configure

Unipolar

Sense Polarity Configure

Unipolar

Lead Monitor Configure

Monitor Only

or

c

a

or

c

d

or

c

Unchanged

Unchanged

Unchanged

a

Notify if < 200 ohms Unchanged

Notify if > 4000 ohms 4000 ohms

Monitor Sensitivity 8 8

86

Pacemaker Specifications

Tab le 5. Shipping and Nominal Settings (Continued)

Parameter Shipping Medtronic

Capture Management Adaptive

Amplitude Margin 1.5x (times) 1.5x (times)

Pulse Width Margin 1.5x (times) 1.5x (times)

Minimum Adapted
Amplitude

Minimum Adapted
Pulse Width

Capture Test
Frequency

Acute Phase Days
Remaining

Paced AV (PAV) 150 ms 150 ms

Sensed AV (SAV) 120 ms 120 ms

RAAV Off Off

PVARP 310 ms 310 ms

Atrial Blanking (PVAB) 180 ms 180 ms

Ventricular Refractory
Period

Ventricular Blanking
(after atrial pace)

Sleep Off Off

Non-Competitive Atrial
Pacing

Single Chamber
Hysteresis

PMT Intervention Off Off

PVC Response On On

Ventricular Safety Pacing On On

2.5 V 2.5 V

0.4 ms 0.4 ms

Day at Rest Day at Rest

112 days Unchanged

230 ms 230 ms

28 ms 28 ms

On On

Off Unchanged

a

Nominal

Adaptive

87

Pacemaker Specifications

Tab le 5. Shipping and Nominal Settings (Continued)

Parameter Shipping Medtronic

Implant Detection On/Restart Unchanged

Transtelephonic Monitor Off Unchanged

Extended Telemetry Off Unchanged

Extended Marker Standard Unchanged

FAST Indicators On Unchanged

Serial Number Factory Set Unchanged

Clinician-Selected

Custom Rate Trend Unchanged

Diagnostic

a

At the completion of the 30-minute Implant Detection period, Mode becomes DDDR;
Rate Profile Optimization is enabled; Polarities are automatically configured for all
bipolar models; Capture Management is enabled, and Ventricular Amplitude and Pulse
Width become Adaptive; Sensing Assurance is enabled, and Sensitivity becomes
Adaptive.

b

Value from which adaptive adjustment begins when nominals are programmed.

c

Unipolar-only Model KDR656

d

Models KDR651 and KDR653

Nominal

88

Pacemaker Specifications

Electrical Reset Parameter Settings

Listed below in Table 6 are the pacemaker’s full and partial electrical
reset parameter settings.

Note: “Unchanged” indicates that the parameter setting is
unchanged by a reset.

Table 6. Electrical Reset Parameter Settings

Parameter Partial Electrical

Reset

Mode Unchanged VVI

Mode Switch Unchanged Off

Detect Rate 175 bpm

Detect Duration No Delay

Blanked Flutter Search Unchanged

Lower Rate Unchanged 65 ppm

Upper Tracking Rate Unchanged 120 ppm

Upper Sensor Rate Unchanged 120 ppm

ADL Rate Unchanged 95 ppm

Rate Profile Optimization Unchanged Off

ADL Response 3-Mod. Active

Exertion Response 3-Mod. Frequent

Activity Threshold Med. Low Med. Low

Activity Acceleration 30 sec 30 sec

Activity Deceleration Exercise Exercise

Full Electrical Reset

89

Pacemaker Specifications

Table 6. Electrical Reset Parameter Settings (Continued)

Parameter Partial Electrical

Reset

Atrial Lead

Amplitude Unchanged 5.0 V

Pulse Width Unchanged 0.4 ms

Sensitivity Unchanged 0.5 mV

Sensing Assurance Unchanged Off

Pace Polarity Unchanged Configure

Sense Polarity Unchanged Configurea or

Lead Monitor Unchanged Configure or

Notify if < 200 ohms 200 ohms

Notify if > 4000 ohms 4000 ohms

Monitor Sensitivity 8 8

Ventricular Lead

Amplitude Unchanged 5.0 V

Pulse Width Unchanged 0.4 ms

Sensitivity Unchanged 2.8 mV

Sensing Assurance Unchanged Off

Pace Polarity Unchanged Configure

Sense Polarity Unchanged Configurea or

Lead Monitor Unchanged Configure or

Notify if < 200 ohms 200 ohms

Notify if > 4000 ohms 4000 ohms

Monitor Sensitivity 8 8

Full Electrical Reset

Unipolar

Unipolar

Monitor Only

Unipolar

Unipolar

Monitor Only

a

or

b

b

b

a

or

b

b

b

90

Pacemaker Specifications

Table 6. Electrical Reset Parameter Settings (Continued)

Parameter Partial Electrical

Reset

Capture Management Unchanged Off

Amplitude Margin Unchanged

Pulse Width Amplitude Unchanged

Minimum Adapted

Unchanged

Amplitude

Minimum Adapted

Unchanged

Pulse Width

Capture Test

Day at Rest

Frequency

Acute Phase Days

112 Days

c

Remaining

Paced AV (PAV) 150 ms 150 ms

Sensed AV (SAV) 120 ms 120 ms

RAAV Unchanged Off

Start Rate 80 ppm

Stop Rate 120 ppm

Max Offset -40 ms

PVARP Unchanged 310 ms

Atrial Blanking (PVAB) 180 ms 180 ms

Ventricular Blanking 28 ms 28 ms

Ventricular Refractory

230 ms 230 ms

Period

Sleep Off Off

NCAP Unchanged Off

Single Chamber

Unchanged Off

Hysteresis

PMT Intervention Unchanged Off

PVC Response Unchanged On

Full Electrical Reset

d

91

Pacemaker Specifications

Table 6. Electrical Reset Parameter Settings (Continued)

Parameter Partial Electrical

Reset

Ventricular Safety Pacing Unchanged On

Implant Detection Unchanged On/Restart

Transtelephonic Monitor Unchanged Off

Extended Telemetry Off Off

Extended Marker Standard Standard

FAST Indicators On On

Serial Number Unchanged Zeros

Full Electrical Reset

Clinician-Selected

Off Off

Diagnostic

a

Bipolar Models KDR651 and KDR653 revert to Implant Detection dur ing which polarity
is automatically configured.

b

Unipolar-only Model KDR656

c

If a reset occurs after the completion of Acute Phase Days Remaining, the parameter
will default to 42 days.

d

Sensor varied PVARP is disabled at a full electrical reset.

92

Pacemaker Specifications

Elective Replacement Indicator

Listed below in Table 7 are the pacemaker’s Elective Replacement
Indicators for nonmagnet and magnet modes.

Table 7. Elective Replacement Indicator Conditions

Nonmagnet Mode VVI mode at 65 ppm rate

Magnet Mode VOO mode at 65 ppm rate

Telemetry Replacement message on programmer

Battery/Lead Information Replacement message and displayed

battery voltage on programmer

Magnet Mode Conditions

Listed below in Table 8 are the pacemaker’s Magnet Mode
Conditions in dual and single chamber modes.

Table 8. Magnet Mode Conditions

Dual Chamber Modes DOO mode at 85 ppm

VDD Mode VOO mode at 85 ppm

Single Chamber Modes VOO/AOO mode at 85 ppm

93

Pacemaker Specifications

Longevity Projections

Listed below in Table 9 are the longevity projections from implant to
the Elective Replacement Indicator (ERI) for the K

DR650 Series

pacemakers. The estimated time varies based on the lead
impedance and the percent paced.

Table 9. Projected Longevity from Implant to ERI

Programmed Settings Percent

Mode: DDDR Lead Impedance

Lower Rate: 60 ppm 500

Nominal Outputs

Amplitudes: 3.5 V
Pulse Widths: 0.4 ms

Low Outputs

Amplitudes: 2.5 V
Pulse Widths: 0.4 ms

Lower Ventricular

Outputs

A. Amplitude: 2.5 V
V. Amplitude 1.5 V
Pulse Widths: 0.4 ms

Paced

100%

50%

100%

50%

100%

50%

Projected Longevity

(Years)

ohms

6.3

7.7

7.7

8.6

8.1

8.9

600

ohms

6.6

8.0

8.0

8.8

8.3

9.0

1000

ohms

7.7

8.8

8.6

9.2

8.8

9.4

Warning: When the Elective Replacement Indicator (ERI) is set, the
pacemaker will continue to operate at ERI conditions for a minimum
of three months until the battery depletes.

Note: The values above are based on calculations using deliverable
battery capacity. These values are estimates of longevity projections
from implant to ERI and are intended to assist the clinician in
understanding the effects of various pacing conditions on battery

94

Pacemaker Specifications

longevity. These values should not be interpreted as precise
projections.

Listed below in Table 10 are the longevity projections from ERI to
erratic pacing for the K

DR650 Series pacemakers. At most

programmed settings, virtually all (i.e., 99.9%) of these pacemakers
will achieve a minimum of three months longevity after ERI is set.

Note: The average time in the table below refers to the projected
mean longevity of pacemakers at the stated conditions.

Table 10. Longevity from ERI to Erratic Pacing

Previous Programmed
Settings Before ERI

Lower Rate: 60 ppm
Amplitudes: 3.5 V
Pulse Widths: 0.4 ms

Mode: DDDR 100% 5.0 11.0

Mode: VVIR 100% 4.0 8.5

a

Programmed settings which lead to increased current demands in VVI, 65-ppm
operating condition after ERI may slightly decrease average projections. Increased
current demands post-ERI could be caused by an increase in the percent paced and/
or the increase in pacing rate.

b

Current data show that combinations of extreme pacing conditions (high output values
[≥ 5.0 V] and high pulse widths, and /or low impedance values [300 ohms] may increase
the average projection in the DDDR/DDD modes and decrease the average projection
in the AAI/AAIR and VVI/VVIR modes.

Percent

Paced

Projected Longevity

(Months)

Lead Impedance

500 ohms

Minimum Average

a,b

95

Pacemaker Specifications

Programmable Parameters

Listed below in Table 11 through Table 19 are the pacemaker’s
programmable modes and parameters.

Table 11. Pacing Modes and Rates

Parameter Capability Notes

Pacing Mode DDDR, DDD, VDD, DDIR,

Mode Switch On, Off DDDR, DDD, VDD

Detect Rate 120, 125, 130, … 200 bpm

Detection Duration No Delay Nonprogrammable

Blanked Flutter
Search

Lower Rate 30, 35, 40, … 175 ppm

Upper Tracking Rate 80, 90, 95, … 180 ppm DDDR, DDD, VDD

Upper Sensor Rate 80, 90, 95, … 180 ppm

DDI, DVIR, DVI, DOOR,
DOO, VVIR, VDIR, VVI,
VDI, VVT, VOOR, VOO,
AAIR, ADIR, AAI, ADI,
AAT, AOOR, AOO, ODO,
OVO, OAO

On, Off

(except 65 and 85 ppm)

modes

modes

Rate responsive
modes or DDD and
VDD modes with
mode switching

96

Pacemaker Specifications

Table 12. Rate Response Parameters

Parameter Capability Notes

ADL Rate 60, 65, 70, … 180 ppm Rate responsive

modes or DDD and
VDD modes with
mode switching

Rate Profile
Optimization

ADL Response 1-Inactive

Exertion Response 1-Infrequent

ADL Setpoint 5, 6, 7, … 40,

UR Setpoint 15, 16, 17, … 40,

Activity Threshold Low, Medium Low,

Activity Acceleration 15, 30, 60 sec

Activity Deceleration 2.5, 5.0, 10 min, Exercise

On, Off, Rate responsive

2-Less Active
3-Mod. Active
4-More Active
5-Very Active

2-Less Frequent
3-Mod. Frequent
4-More Frequent
5-Very Frequent

42, 44, 46, … 80

42, 44, 46, … 80,
85, 90, 95, … 180

Medium High, High

modes

Programmable from
the Exercise test only

Programmable from
the Exercise test only

97

Pacemaker Specifications

Table 13. Atrial Outputs, Sensitivity, and Polarity

Parameter Capability Notes

Amplitude

a

0.5, 0.75, 1.0 … 4.0 V

4.5, 5.0, 5.5, 6.0 V, 7.5 V

Pulse Width 0.12, 0.15, 0.21, 0.27,

0.34, 0.40, 0.46, 0.52,

0.64, 0.76, 1.00, 1.25,

1.50 ms

Sensitivity 0.18, 0.25, 0.35, 0.5, 0.7,

1.0, 1.4, 2.0, 2.8, 4.0 mV

0.18, 0.25, 0.35 mV
atrial bipolar only

Sensing Assurance On, Off

Pacing Polarity Bipolar, Unipolar,

Configure

DR656 is

Model K
unipolar only.
Configure is displayed
but is not selectable.

Sensing Polarity Bipolar, Unipolar,

Configure

DR656 is

Model K
unipolar only.
Configure is displayed
but is not selectable.

Lead Monitor Configure, Monitor Only,

Adaptive, Off

DR656 only

Model K
operates in Monitor
Only

Notify if < 200 ohms Nonprogrammable

Notify if > 1000, 2000, 3000,

4000 ohms

Monitor Sensitivity 2, 3,4, … 16

a

Tolerance for amplitudes from 0.5 V through 6.0 V is ± 10%, and for 7.5 V is

-20/+0%. Tolerances are based on 37°C and a 500-ohm load.

98

Pacemaker Specifications

Table 14. Ventricular Outputs, Sensitivity, and Polarity

Parameter Capability Notes

Amplitude

a

0.5, 0.75, 1.0 … 4.0 V

4.5, 5.0, 5.5, 6.0 V, 7.5 V

0.625, 0.875, 1.125,

1.375, 1.625, and

1.875 V can be set by
Capture Management.
Values are displayed,
but not selectable.

Pulse Width 0.12, 0.15, 0.21, 0.27,

0.34, 0.40, 0.46, 0.52,

0.64, 0.76, 1.00, 1.25,

1.50 ms

Sensitivity 1.0, 1.4, 2.0, 2.8, 4.0, 5.6,

8.0, 11.2 mV

Sensing Assurance On, Off

Pacing Polarity Bipolar, Unipolar,

Configure

DR656 is

Model K
unipolar only. Configure
is displayed but is not
selectable.

Sensing Polarity Bipolar, Unipolar,

Configure

DR656 is

Model K
unipolar only. Configure
is displayed but is not
selectable.

Lead Monitor Configure, Monitor Only,

Adaptive, Off

DR656 only

Model K
operates in Monitor
Only

Notify if < 200 ohms Nonprogrammable

Notify if > 1000, 2000, 3000,

4000 ohms

Monitor Sensitivity 2, 3,4, … 16

a

Tolerance for amplitudes from 0.5 V through 6.0 V is ± 10%, and for 7.5 V is

-20/+0%. Tolerances are based on 37°C and a 500-ohm load.

99

Pacemaker Specifications

Table 15. Capture Management

Parameter Capability Notes

Ventricular Capture

Off, Monitor Only

Management

Amplitude Margin 1x, 1.25x, 1.5x, 2x,

2.5x (times)

Pulse Width Margin 1x, 1.5x, 2x, 2.5x, 3x,

4x, 5x (times)

Minimum Adapted
Amplitude

Minimum Adapted
Pulse Width

0.5, 0.625, 0.75, 1.0 … 2.0 V

2.25, 2.50 ... 4.0 V, 4.5, 5.0 V

0.12, 0.15, 0.21, 0.27, 0.34,

0.40, 0.46, 0.52, 0.64, 0.76,

1.00 ms

Capture Test
Frequency

Test Capture Every 15, 30 Minutes

1, 2, 4, 8, 12 hours,
Day at Rest, Day at …,
7, 14, 28, 42 Days at ...

At 12:00 am, 12:15 am,

12:30 am, … 11:45 pm

Retry if Test

Ye s , No

Delayed?

Acute Phase Days
Remaining

a

When programmed to Monitor Only, the subparameters shown in the table above are
programmable for use by the pacemaker in providing suggested output values.

Off, 7, 14, 21, … 84 days
112, 140, 168, … 252 days

a

, Adaptive

Applicable only
for Day(s) at …
parameter

100