Medtronic KDR706 Technical Manual

KAPPA® DR700 SERIES

197881003A__view.pdf

PacemakerModels KDR700/720/730

Product Information Manual

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

Medtronic Kappa® 700
Series Pacemaker Product
Information Manual

Models KDR701/703/706, KDR721, and

DR731/733

K

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:

Auto PVARP, Capture Management, FAST, Implant Detection,
Kappa, Key Parameter History, Marker Channel, Medtronic,
Medtronic Kappa, Medtronic Vision, Rate Profile Optimization,
Remote Assistant, Search AV, Sensing Assurance, Sinus
Preference, and Vision.

Table of contents

Chapter 1 - Prescribing the Pacemaker 7

Device Description 8
Indications and Usage 9
Contraindications 10
Warnings and Precautions 11
Co-implantation with an Implantable Defibrillator 21
Adverse Events 23
Clinical Studies 27

Chapter 2 - Implanting the Pacemaker 31

Implantation Procedures 32
Implant Documentation 42
Parameter Programming at Implant 43
Medical Therapy Interactions 49
Assistance 52

Chapter 3 - Description 53

Pacing Mode Operations 54
Rate Responsive Pacing 57
Timing Operations 58
Pacing and Sensing Operations 64
Special Therapy Options 71

Chapter 4 - Pacemaker Follow-up 79

Pacemaker Telemetry 80
Other Operations 83

5

Diagnostics 87
General Recommendations 89

Appendix 91

NBG Codes 92
Special Notice 93

Pacemaker Specifications 95

Lead Requirements, Compatibility 96
Radiopaque Identification 97
Emergency Parameter Settings 98
Shipping and Nominal Parameter Settings 99
Electrical Reset Parameter Settings 103
Elective Replacement Indicator 108
Magnet Mode Conditions 108
Longevity Projections 109
Programmable Parameters 116
Nonprogrammable Parameters 125
Temporary Parameters 126
Tel e m e t r y M a r k e r s 12 7
Electrograms 127
Automatic Diagnostics 127
Clinician-Selected Diagnostics 128
Patient Information 128
Battery and Lead Telemetered Information 129
Battery Parameters 130
Mechanical Dimensions 131

Index 133

6

Chapter 1 - Prescribing the Pacemaker

Device Description 8

Indications and Usage 9

Contraindications 10

Warnings and Precautions 11

Co-implantation with an Implantable Defibrillator 21

Adverse Events 23

Clinical Studies 27

7

Device Description

Device Description

Medtronic Kappa 700 Series pacemakers (KDR700 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

DR701, KDR721,

DR731

and K

KDR703 and

DR733

K

K

DR706 Unipolar Unipolar 5 or 6 mm

a

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

1992).

DR700 Series pacemakers are programmed using the Medtronic

K

Bipolar/Unipolar IS-1

Bipolar/Unipolar Low-profile 3.2 mm bipolar

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

a

BI

or IS-1a BI

8

Indications and Usage

Indications and Usage

KDR700 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.
– Vasovagal syndromes or hypersensitive carotid sinus

syndromes.

DR700 Series pacemakers are also indicated for dual chamber and

K
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

Contraindications

Contraindications

KDR700 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
cardioverter-defibrillator (ICD) because it may cause
unwanted delivery or inhibition of ICD therapy. See “Co­implantation with an Implantable Defibrillator” on page 21.

10

Warnings and Precautions

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
in no pacing output. See “Manually Programming Polarity” on
page 67 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 64 for further information.

11

Warnings and Precautions

■

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 83 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 74 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 70 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 17 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
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.

12

Warnings and Precautions

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 103.

Resterilization: Acceptable Unacceptable

Do not implant the device if it

has been dropped on a hard
surface from a height of
12 inches (30 cm) or more.

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 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.

°F (60°C) or

13

Warnings and Precautions

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.

■

Pacing and sensing safety margins. Consider lead
maturation when choosing pacing amplitudes, pacing pulse
widths, and sensing levels. See “Manual Programming” on
page 45.

■

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 36 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 K
Series pacemakers.

■

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 Analyser (PSA). Medtronic does not recommend using
a constant current device such as the Medtronic Model 5880A
or 5375 External Pacemaker because the Kappa DR
pacemaker has constant voltage output circuits.

■

Crosstalk occurs in dual chamber systems when atrial pacing
output pulses are sensed by the ventricular lead. Crosstalk

DR700

14

Warnings and Precautions

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.

■

Elective Replacement Indicator (ERI). When ERI is set, the
pacemaker must be replaced within three months. See
“Elective Replacement Indicator” on page 86 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 85 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 73 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.

15

Warnings and Precautions

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.

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 50 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

16

Warnings and Precautions

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,
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.

17

Warnings and Precautions

– Reported1 effects of MRI on pacing include increased

ventricular pacing beyond the rate limit.

■

Radiofrequency ablation procedure in a patient with a

DR700 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.

1

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

18

Warnings and Precautions

■

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.

■

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

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.

19

Warnings and Precautions

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

20

824 - 849 MHz

Co-implantation with an Implantable Defibrillator

Co-implantation with an Implantable
Defibrillator

■

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

– The use of unipolar-only Model KDR706 and the KDR700

Series bipolar models implanted with unipolar leads is
contraindicated for patients having an implantable
defibrillator.

– Follow implant protocol and precautions for pacemaker

and defibrillator lead placement. Ensure that 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 64 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.

21

Co-implantation with an Implantable Defibrillator

■

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.

■

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.

22

Adverse Events

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.

There were a total of six deaths in the 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.

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 .

23

Adverse Events

Table 2. Adverse Events Reported in Four or More Patients-

Complications

a

(Comps) and Observationsb (Obs)

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

c

% of

Patients

with
Comps
(n=285)

Comps

per

Device-

Year

(n=133)

% of

Patients

with Obs

(n=285)

Obs per

Device-

Year

(n=133)

Event Total

Number

of

Events

(Patients)

Any adverse

355 (168) 17.2% 0.45 52% 2.22

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

24

Adverse Events

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).

25

Adverse Events

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).

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

26

Clinical Studies

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.

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
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.

1

) at their one

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.

27

Clinical Studies

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.

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

28

Clinical Studies

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

The Medtronic Kappa 700 Series pacemaker’s Rate Profile
Optimization (RPO) governs sensor indicated rate (SIR) output.
Figure 1 shows the SIR vs. the Wilkoff predicted heart rate achieved
using the RPO feature during the MPREP tests at 1 month.

29

Clinical Studies

All patients reaching Anaerobic Threshold, N=87

Expected (Wilkoff) rate, mean and 95% CI

100

90

80

70

60

50

40

30

SIR (normalized)

20

10

0

0 204060

p

p

U

I

C

5%

9

r

e

n

a

e

M

Lower 95% CI

S

e

t

c

e

p

x

E

)

7

8

=

N

(

R

I

MPREP Workload (normalized)

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

)

f

f

o

k

l

i

W

(

d

80

R

I

S

100

30

Chapter 2 - Implanting the Pacemaker

Implantation Procedures 32

Implant Documentation 42

Parameter Programming at Implant 43

Medical Therapy Interactions 49

Assistance 52

31

Implantation Procedures

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)

32

Implantation Procedures

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.

33

Implantation Procedures

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 K

DR700 Series models.

34

Implantation Procedures

Connecting Leads to the Pacemaker

KDR700 Series pacemakers have two lead connector ports. All
models except the unipolar-only Model K
connector contact aligned behind one another. (See Figure 2.)

DR706 have a tip and ring

Tip Electrodes

Ring Electrodes

Atrial Port

Ventricular Port

Figure 2. Example of Bipolar Connector Assembly for

Model K

DR701

The Models KDR701, KDR721, KDR731 use a setscrew to contact the
lead tip electrode, but do not use a setscrew to contact the ring
electrode. The Models K

DR703 and KDR733 contact the lead with

setscrews at the tip and ring electrodes.

For information regarding acceptable lead type for each model, refer
to “Lead Requirements, Compatibility” on page 96.

35

Implantation Procedures

Connection Procedure

Connecting the leads to the pacemaker 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.
The rubber connector seal maintains the torque wrench
in position.

36

Implantation Procedures

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

Models K
K

Models K

Model K

DR701,

DR721, KDR731

DR703, KDR733 IS-1 BI Just becomes visible

DR706 5 or 6 mm unipolar Visible at end of area

IS-1 BI Visible at end of area

Low-profile

3.2 mm bipolar

Visible at end of area

37

Implantation Procedures

KDR701, KDR721, KDR731

K

DR706

K

DR703, KDR733

(IS-1 BI leads)

Figure 4. Lead Insertion Viewing Area

KDR703, KDR733

(with 3.2 mm bipolar leads)

38

Implantation Procedures

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.

KDR701, KDR721, KDR731

K

DR706

K

DR703, KDR733

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 overtorqued to prevent damage to the socket or the
setscrews. Bending the wrench may break it.

39

Implantation Procedures

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.

40

Implantation Procedures

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.

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 50 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, CPI, Intermedics, 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.

41

Implant Documentation

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.

42

Parameter Programming at Implant

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 99 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 44.

43

Parameter Programming at Implant

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 Ventricular Amplitude
and Pulse Width become adaptive.

■

Sensing Assurance is enabled, and Sensitivity becomes
adaptive.

■

Search AV is enabled, and Paced AV and Sensed AV become
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.

44

Parameter Programming at Implant

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 the 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,
palpitations, etc.).

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” or “auto” 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.

45

Parameter Programming at Implant

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
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.

46

Parameter Programming at Implant

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.

47

Parameter Programming at Implant

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, Rate Adaptive AV (RAAV), and Search AV.

■

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

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,

■

Rate Drop Response for backup pacing during drops in
heart rate,

■

Sinus Preference for a greater range of sinus activation of the
ventricles, 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.

48

Medical Therapy Interactions

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 KDR706 and the KDR700
Series bipolar models implanted with unipolar leads is
contraindicated for patients having an implantable defibrillator.

■

KDR700 Series bipolar models 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 64.) 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.

■

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

DR700 Series models in patients having an

49

Medical Therapy Interactions

– 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.

Warni ng: 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.

Warni ng: 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.

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.

50

Medical Therapy Interactions

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.

X-ray and Fluoroscopy

X-ray and fluoroscopy testing of pacemakers similar to the KDR700
Series pacemakers by exposure to diagnostic X-ray or fluoroscopic
radiation has not affected those pacemakers.

51

Assistance

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.

52

Chapter 3 - Description

Pacing Mode Operations 54

Rate Responsive Pacing 57

Timing Operations 58

Pacing and Sensing Operations 64

Special Therapy Options 71

53

Pacing Mode Operations

Pacing Mode Operations

A brief description of programmable mode operations is given below.

Warni ngs:

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

54

Pacing Mode Operations

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).

55

Pacing Mode Operations

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.

Warni ng: 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.

56

Rate Responsive Pacing

Rate Responsive Pacing

The KDR700 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.

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.

57

Timing Operations

■

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.

Timing Operations

A-A Timing and Mean Atrial Rate

KDR700 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 and automatic
Post-Ventricular Atrial Refractory Period (PVARP) operation.

Rates

The pacemaker has 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.

58

Timing Operations

■

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.
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, Search 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, Search AV, automatic
PVARP, or Capture Management operation or may be
extended as the result of Wenckebach operation if the intrinsic
atrial rate exceeds the UTR.

59

Timing Operations

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.

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.

60

Timing Operations

Search AV

The Search AV feature provides the physician with two methods for
measuring and responding to AV conduction in patients with intact or
intermittent AV conduction. By adjusting the programmed AV
intervals to the patient’s intrinsic AV conduction, the pacemaker can
mimic normal physiology and promote tracking of fast atrial rates.

■

When Search AV is programmed to Adaptive, the pacemaker
evaluates conduction every 16 AV sequences. Based on the
measured conduction times for the 16 AV sequences, the
pacemaker classifies the AV complexes as too short, too long,
or adequate. If the complexes are adequate, no adjustment is
made, but if they are too short or long, the pacemaker adds or
subtracts to the SAV and PAV for the next 16 pacing cycles to
promote intrinsic activation. The programmable Maximum
Offset defines the maximum amount by which the PAV and/or
SAV intervals can be lengthened.

If Rate Adaptive AV is On, the pacemaker adjusts the AV
intervals above the Rate Adaptive AV curve to promote
intrinsic conduction. If Rate Adaptive AV is Off, it adjusts the
intervals above the programmed PAV and SAV values.

Search AV, programmed to adaptive, becomes operational
automatically when Implant Detection is completed.

■

When Search AV is programmed to a fixed AV hysteresis delay
value, the pacemaker modulates the AV intervals according to
whether or not the previous complex ended in a ventricular
pace or sense. If a ventricular sense, the SAV and PAV for the
next cycle will be lengthened by the programmed fixed AV
hysteresis delay value.

Note: The pacemaker cannot operate adaptively and at a fixed
hysteresis setting simultaneously.

61

Timing Operations

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,
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
Post-Ventricular 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 automatic PVARP protects against

PMTs and against transitory 2:1 block in tracking modes.
Automatic PVARP maintains an appropriately high 2:1
block rate by calculating a new target 2:1 block point,

62

Timing Operations

based on the Mean Atrial Rate plus 30 bpm, every four
pacing cycles. The pacemaker then adjusts the PVARP to
produce a Total Atrial Refractory Period equal to the target
2:1 block point. The minimum 2:1 block point is 100 bpm,
and the maximum is the Upper Tracking Rate plus 35 bpm.
The programmable Minimum PVARP parameter defines
the limit to which the PVARP can be adjusted.

■

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.

■

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.

63

Pacing and Sensing Operations

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 K
polarities are automatically or manually programmable and are
independently programmable for the atrial and ventricular channels.
The Model 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:

DR700 Series bipolar pacemakers, pacing and sensing

DR706 provides unipolar pacing and sensing only.

■

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.

■

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

64

Pacing and Sensing Operations

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 66.

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.

– 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

65

Pacing and Sensing Operations

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.

Warni ng: When implanting a Model K

DR703 or KDR733 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 KDR706
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.

66

Pacing and Sensing Operations

Manually Programming Polarity

Pacing and Sensing Polarities for the bipolar models 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.

Warni ng: 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).

67

Pacing and Sensing Operations

■

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

– 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

DR706 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.

Warni ng: Lead Monitor should not be programmed to Adaptive for
patients with an implantable defibrillator. 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.

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

68

Pacing and Sensing Operations

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
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 43.

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.

DR700 Series pacemakers, sensitivity is automatically

Pacing Output

Amplitude and Pulse Width determine the pacing pulse strength
necessary to capture the atrium and ventricle. Amplitude and Pulse

69

Pacing and Sensing Operations

Width are both manually programmable for the atrial and ventricular
channels or automatically programmable for the ventricular channel
through the Capture Management feature. Amplitude and Pulse
Width can also be programmed on a temporary basis. Refer to
“Parameter Programming at Implant” on page 43 for pacing output
guidelines.

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 lower limit to which Amplitude and Pulse Width can
be set by the pacemaker during adaptation.

■

Acute Phase Days Remaining – time in days during which the
pacemaker will not decrease output settings below the initially
programmed settings. This parameter is used during the lead
maturation period.

70

Special Therapy Options

Capture Management becomes operational automatically when
Implant Detection is completed.

Warni ng: 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.

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) and is
sustained for the programmed Detect Duration (time period

71

Special Therapy Options

confirming continuation of the tachycardia), the pacemaker switches
mode and gradually changes the ventricular rate to the sensor­indicated 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.

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.

72

Special Therapy Options

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.

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

73

Special Therapy Options

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 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.

Warni ng: VSP should always be programmed On for pacemaker­dependent patients.

74

Special Therapy Options

Rate Drop Response

Rate Drop Response (RDR) is a programmable On or Off feature that
provides backup pacing for patients who experience symptomatic
episodes of heart rate drop. RDR intervenes by pacing both
chambers at an elevated rate (programmed Intervention Rate) for a
specific duration (programmed Intervention Duration). At the
conclusion of the Intervention Duration, the pacing rate gradually
returns to the programmed Lower Rate. Two programmable detection
methods may be selected, either separately or in tandem:

■

Low Rate Detect, in which the pacemaker monitors for a
programmable number of paces at the Lower Rate (Detection
Beats) required to trigger an intervention.

■

Drop Detect, in which the pacemaker monitors a rate drop
which must meet two programmable requirements to trigger an
intervention. The programmable Drop Size is the number of
beats the rate must fall within the Detection Window
(programmable amount of time monitored for a rate drop) in
order for an RDR episode to be detected. The programmable
Drop Rate is the threshold that the rate must fall below during
the Detection Window in order to trigger an intervention.

RDR is programmable in the DDD or DDI mode only.

75

Special Therapy Options

Sinus Preference

Sinus Preference, programmable On or Off in the DDDR mode only,
searches for or tracks an intrinsic sinus rate that is lower than the
sensor-indicated rate. This operation is determined by two
programmable parameters:

■

The Search Interval is the amount of time spent pacing
between sinus search operations.

■

The Sinus Preference Zone is the maximum allowable
reduction in rate relative to the sensor-indicated rate.

Two modalities determine how a sinus rate may emerge. During
sinus search operation, the pacemaker searches for a lower intrinsic
rate within the Sinus Preference Zone. If the sinus rate is present, it
is tracked by the ventricle. If it is not, pacing occurs for 8 beats at the
maximum allowable reduced rate as defined by the Sinus Preference
Zone, then the rate gradually returns to the sensor-indicated rate.

In sinus breakthrough operation, a sinus rate may be tracked below
the sensor-indicated rate as long as it remains within the Sinus
Preference Zone. If the intrinsic rate falls below the Sinus Preference
Zone, the pacemaker paces at the maximum allowable reduced rate
for eight paces and gradually returns to the sensor-indicated rate.

76

Special Therapy Options

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.

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.

77

Chapter 4 - Pacemaker Follow-up

Pacemaker Telemetry 80

Other Operations 83

Diagnostics 87

General Recommendations 89

79

Pacemaker Telemetry

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.

80

Pacemaker Telemetry

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.

Warni ng: 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.

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

81

Pacemaker Telemetry

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.

Warni ng: 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.

82

Other Operations

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.

83

Other Operations

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

The FAST is available with the patient-activated hand-held Remote
Assistant when the Remote Assistant diagnostic is off, and FAST has
been programmed On.

With the 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, Sensitivity, and AV intervals.

84

Other Operations

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 103 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.

85

Other Operations

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
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
“Emergency Parameter Settings” on page 98.

86

Diagnostics

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.

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.

■

Search AV Histogram. Automatically collects conduction
sequences resulting from the Search AV function.

■

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

87

Diagnostics

and VVT). This data is not collected in non-pacing modes
(OAO, OVO, and ODO).

■

Key Parameter History. Automatically records the status of key
parameters pertaining to the last eight programming sessions.

■

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 and, optionally,
clinician-selected detailed data reporting the results of pacing
threshold tests.

■

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

■

Sinus Preference Episodes. Automatically collects data from
searches for the sinus rate and intrinsic sinus breakthrough
episodes.

■

Rate Drop Response Episodes. Automatically collects basic
data on rate drops and Rate Drop Response therapy
intervention, and, optionally, clinician-selected rate trend
information for Rate Drop Response.

■

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

■

AV Interval Histogram. Clinician-selected option allows you to
program the pacemaker to collect AV interval data for display
in the form of a histogram.

■

Lead Monitor Impedance Trend. Provides trend data on the
integrity of the lead.

■

Sensitivity Detail. Provides a detailed view of Sensing
Assurance operation by recording sensitivity values at 1-hour
intervals.

1

88

General Recommendations

■

Remote-Assistant Symptoms. Data for symptom diagnosis is
collected by the clinician-selected atrial and ventricular beat­to-beat rate trend with optional EGM.

Data collection is initiated by the patient using the Remote
Assistant patient activator. The patient will hear a clicking
sound from the Remote Assistant when initiating a telemetry
link with the pacemaker. If the link is successful, the Remote
Assistant responds with three beeps, and a green light
appears on the underside of the activator. If communication is
unsuccessful, it responds with two beeps in a lower tone, and
a yellow light appears instead.

■

Remote-Assistant Exercise. Records heart rate data for a
trend graph during a particular exercise activity.

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.

1

If you selected Sensitivity Detail as one of the setup options for Capture Management
Detail, the recording interval is 2 hours rather than 1 hour.

89

Appendix

Appendix

NBG Codes

Special Notice 93

92

91

NBG Codes

NBG Codes

The KDR700 Series pacemakers may be described as DDDR
pacemakers using the NBG

1

code (NBG code stands for “The North
American Society of Pacing and Electrophysiology [NASPE] and the
British Pacing and Electrophysiology Group [BPEG] Generic”). The
five-letter code, which supersedes the ICHD Code, describes the
operation of implantable pacemakers. For simplicity, this manual
uses only the first three or four letters, e.g., DDIR, DVIR, DDD, etc.
The following chart describes the first four letters of the NBG code.

CHAMBER PACED

V

=

Ventricle

A

=

Atrium

D

=

Dual Chamber

S

=

Single Chamber

O

=

None

CHAMBER SENSED

V

=

Ventricle

A

=

Atrium

D

=

Dual Chamber

S

=

Single Chamber

O

=

None

DDDR

MODE OF RESPONSE

T

=

Triggered

I

=

Inhibited

D

=

Double (Both)

O

=

None

PROGRAMMABLE/
RATE RESPONSE

P

=

Programmable

M

=

Multiprogrammable

C

=

Communicating

R

=

Rate Responsive

O

=

None

1

Bernstein A., et al., The NASPE/BPEG Pulse Generator Code, Pace, 10 (4),
Jul-Aug 1987.

92

Special Notice

Special Notice

Medtronic implantable pacemakers and leads are implanted in the
extremely hostile environment of the human body. This environment
places severe limitations on the design and function of the
pacemaker and lead. These limitations unavoidably reduce the
potential performance and longevity of the pacemaker and lead
despite the exercise of due care in design, component selection,
manufacture and testing prior to sale. Reference is hereby made to
published data on predictable failure rates of the pacemaker and lead
and their implantation which have either been furnished by Medtronic
or are otherwise available to physicians. The pacemaker includes an
inseparable power source which will ultimately cease to function due
to exhaustion or premature failure thereby necessitating removal of
the pacemaker. The lead is necessarily very small in diameter and
very flexible, which unavoidably increases the likelihood of breakage
or breach of its insulation. Other reasons for failure of the pacemaker
or lead include, but are not limited to: body rejection phenomena;
change in performance characteristics due to component changes or
failures; unusual physiological variations in patients; lead
displacement; lead fracture; fibrotic tissue formation; elevated
thresholds; medical complications, such as myocardial infarction
occurring at the site of the electrode; erosion of the pacemaker or
lead through body tissue or interference from transmitters, tools,
appliances, instruments, equipment or other devices which use
electricity or electromagnetic wave transmission. Consequently, no
representation or warranty is made that failure or cessation of
function of the pacemaker or lead will not occur, that the body will not
react adversely to the implantation of the pacemaker or lead, that
medical complications will not follow the implantation of the
pacemaker or lead or that the pacemaker and lead will, in all cases,
restore adequate cardiac function.

93

Pacemaker Specifications

Pacemaker Specifications

Lead Requirements, Compatibility 96

Radiopaque Identification 97

Emergency Parameter Settings 98

Shipping and Nominal Parameter Settings 99

Electrical Reset Parameter Settings 103

Elective Replacement Indicator 108

Magnet Mode Conditions 108

Longevity Projections 109

Programmable Parameters 116

Nonprogrammable Parameters 125

Temporary Parameters 126

Telemetry Markers 127

Electrograms 127

Automatic Diagnostics 127

Clinician-Selected Diagnostics 128

Patient Information 128

Battery and Lead Telemetered Information 129

Battery Parameters 130

Mechanical Dimensions 131

95

Lead Requirements, Compatibility

Lead Requirements, Compatibility

The chart below lists the available models by polarity type with the
required lead for proper operation. Refer to “Implant Documentation”
on page 42.

Model Polarity Primary Leads Connector

K

DR701
DR721

K

DR731

K

DR703

K

DR733

K

DR706 Unipolar Unipolar 5 or 6 mm Setscrew for

K

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.

Bipolar/Unipolar IS-1

Bipolar/Unipolar Low-profile 3.2 mm

a

BI

bipolar or IS-1a BI

Setscrew for
tip electrode

Setscrews for
tip and ring
electrodes

tip electrode

96

Radiopaque Identification

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 Models Radiopaque

DR701 PGU KDR721 PGR

K

K

DR703 PGY KDR731 PHB

K

DR706 PGW KDR733 PHD

PGU

Figure 7. Model KDR701 X-Ray

DR701 is given in

97

Emergency Parameter Settings

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

98

Shipping and Nominal Parameter Settings

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

a

Mode DDD (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

) DDDR

Nominal

Unchanged

99

Shipping and Nominal Parameter Settings

Table 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

Unipolar

Unipolar

c

a

c

d

Monitor Only

or

or

or

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

a

Amplitude 3.5 V (Adaptive

Pulse Width 0.4 ms (Adaptive

Sensitivity 2.8 mV (Adaptive

Sensing Assurance On

a

Pace Polarity Configure

Unipolar

Sense Polarity Configure

Unipolar

Lead Monitor Configure

Monitor Only

)3.5V

a

)0.4msb (Adaptive)

a

)2.8mVb (Adaptive)

a

or

c

a

or

c

d

or

c

Notify if < 200 ohms Unchanged

Notify if > 4000 ohms 4000 ohms

Monitor Sensitivity 8 8

100

b

(Adaptive)

On

Unchanged

Unchanged

Unchanged