Medtronic KDR651 Technical Manual
KAPPA® DR650 SERIES
198798002A_view.pdf
198798002A_view.pdf
Pacemaker Models KDR651/653/656
Product Information Manual
Caution: Federal Law (USA) restricts this device
to sale by or on the order of a physician (or
properly licensed practitioner).
Kappa®650 Series Pacemaker
Product Information Manual
Models KDR651, KDR653, and KDR656
3
This Product Information Manual is primarily intended as an
implantation manual. For programming information see the
Pacemaker Reference Guide that accompanies the programmer
software. It is primarily intended as a follow-up manual, and contains
further information on therapeutic and diagnostic features,
troubleshooting information, follow-up precautionary information,
and complete reference information.
The following are trademarks of Medtronic:
Capture Management, FAST, Implant Detection, Kappa, Marker
Channel, Medtronic, Medtronic Kappa, Medtronic Vision, Rate
Profile Optimization, Sensing Assurance, and Vision.
4
Table of Contents
Chapter 1 - Prescribing the Pacemaker 7
Device Description 8
Indications and Usage 9
Contraindications 10
Warnings and Precautions 10
Co-implantation with an Implantable Defibrillator 20
Adverse Events 22
Clinical Studies 25
Chapter 2 - Implanting the Pacemaker 29
Implantation Procedures 30
Implant Documentation 39
Parameter Programming at Implant 40
Medical Therapy Interactions 45
Assistance 48
Chapter 3 - Description 49
Pacing Mode Operations 50
Rate Responsive Pacing 52
Timing Operations 54
Pacing and Sensing Operations 58
Special Therapy Options 65
Chapter 4 - Pacemaker Follow-up 71
Pacemaker Telemetr y 72
Other Operations 75
5
Diagnostics 79
General Recommendations 80
Pacemaker Specifications 81
Lead Requirements, Compatibility 82
Radiopaque Identification 83
Emergency Parameter Settings 84
Shipping and Nominal Parameter Settings 85
Electrical Reset Parameter Settings 89
Elective Replacement Indicator 93
Magnet Mode Conditions 93
Longevity Projections 94
Programmable Parameters 96
Nonprogrammable Parameters 103
Temporary Parameters 104
Tel e m e tr y M a r k e rs 10 5
Electrograms 105
Automatic Diagnostics 105
Clinician-Selected Diagnostics 106
Patient Information 106
Battery and Lead Telemetered Information 107
Battery Parameters 108
Mechanical Dimensions 108
Appendix 109
NBG Codes 110
Special Notice 111
Index 113
6
Prescribing the Pacemaker
Chapter 1 - Prescribing the Pacemaker
Device Description 8
Indications and Usage 9
Contraindications 10
Warnings and Precautions 10
Co-implantation with an Implantable Defibrillator 20
Adverse Events 22
Clinical Studies 25
7
Prescribing the Pacemaker
Device Description
Medtronic Kappa 650 Series pacemakers (KDR650 Series) are dual
chamber, multiprogrammable, rate responsive, implantable
pacemakers, intended for a variety of bradycardia pacing
applications. Rate response is controlled through an activity-based
sensor. The following models are available:
Model Polarity Primary Leads
K
DR651 Bipolar/Unipolar IS-1
KDR653 Bipolar/Unipolar Low-profile 3.2 mm bipolar
K
DR656 Unipolar Unipolar 5 or 6 mm
a
IS-1 refers to an International Connector Standard (see Document No. ISO 5841-3;
1992).
DR650 Series pacemakers are programmed using the Medtronic
K
Vision software Model 9953 and a Medtronic Model 9790
programmer. For programming instructions, refer to the Pacemaker
Programming Guide that accompanies Medtronic Kappa 700/650
Series software.
a
or IS-1
BI
a
BI
8
Prescribing the Pacemaker
Indications and Usage
KDR650 Series pacemakers are indicated for the following:
■
Rate adaptive pacing in patients who may benefit from
increased pacing rates concurrent with increases in activity.
■
Accepted patient conditions warranting chronic cardiac pacing
which include:
– Symptomatic paroxysmal or permanent second or
third-degree AV block.
– Symptomatic bilateral bundle branch block.
– Symptomatic paroxysmal or transient sinus node
dysfunctions with or without associated AV conduction
disorders.
– Bradycardia-tachycardia syndrome to prevent
symptomatic bradycardia or some forms of symptomatic
tachyarrhythmias.
KDR650 Series pacemakers are also indicated for dual chamber and
atrial tracking modes in patients who may benefit from maintenance
of AV synchrony. Dual chamber modes are specifically indicated for
treatment of conduction disorders that require restoration of both rate
and AV synchrony, which include:
■
Various degrees of AV block to maintain the atrial contribution
to cardiac output.
■
VVI intolerance (e.g., pacemaker syndrome) in the presence of
persistent sinus rhythm.
9
Prescribing the Pacemaker
Contraindications
KDR650 Series pacemakers are contraindicated for the following
applications:
■
Dual chamber atrial pacing in patients with chronic refractory
atrial tachyarrhythmias.
■
Asynchronous pacing in the presence (or likelihood) of
competitive paced and intrinsic rhythms.
■
Unipolar pacing for patients with an implanted cardioverterdefibrillator (ICD) because it may cause unwanted delivery or
inhibition of ICD therapy. See “Co-implantation with an
Implantable Defibrillator” on page 20.
Warnings and Precautions
■
Rate responsive modes. Do not use rate responsive modes
in those patients who cannot tolerate pacing rates above the
programmed Lower Rate.
■
Single chamber atrial modes. Do not use single chamber
atrial modes in patients with impaired AV nodal conduction
because ventricular capture cannot be assured.
Pacemaker Dependent Patients
■
Diagnostic modes. Never program diagnostic modes (ODO,
OVO, and OAO) for pacemaker-dependent patients. For such
patients, use the programmer’s inhibit function for brief
interruption of outputs.
■
Electrogram (EGM) of the patient’s intrinsic activity should be
obtained with care since the patient is without pacing support
when using the programmer’s inhibit function.
■
Polarity override. Overriding the bipolar verification prompt
with bipolar polarity when a unipolar lead is connected results
10
Prescribing the Pacemaker
in no pacing output. See “Manually Programming Polarity” on
page 61 for further information.
■
A false bipolar pathway on a unipolar lead, a possible
occurrence with bipolar 3.2 mm connector pacemakers, may
result in a loss of output. See the warning in “Automatic
Polarity Configuration” on page 58 for further information.
■
Loss of capture during threshold margin test (TMT) at a
20% reduction in amplitude indicates that the stimulation
safety margin is inadequate. Consider increasing the pacing
amplitude and/or pulse width. See “Magnet Operation” on
page 75 for further information on the Threshold Margin Test.
■
Ventricular safety pacing should always be used for
pacemaker-dependent patients. See “Ventricular Safety
Pacing” on page 68 for further information.
■
Capture Management will not program ventricular outputs
above 5.0 V or 1.0 ms. If the patient needs a pacing output
higher than 5.0 V or 1.0 ms, program Amplitude and Pulse
Width manually. See “Capture Management” on page 64 for
further information
Medical Therapy
■
Therapeutic Diathermy can cause fibrillation, burning of
the myocardium, and irreversible damage to the pulse
generator due to induced currents.
■
Magnetic resonance imaging of pacemaker patients has
resulted in significant adverse effects. See “Magnetic
Resonance Imaging (MRI)” on page 16 for further information.
Storage and Resterilization
Medtronic pacemakers are intended for single use only. Do not
resterilize and re-implant explanted pacemakers.
The chart below gives recommendations on handling and storing the
package. Medtronic has sterilized the pacemaker with ethylene oxide
11
Prescribing the Pacemaker
prior to shipment. Resterilizing the pacemaker is necessary if the
seal on the sterile package is broken. Resterilization does not affect
the “Use Before” date.
Handling and Storage: Acceptable Unacceptable
Store and transport within
Environmental Temperature limits:
°F (- 18°C) to 131°F (55°C).
0
Note: A full or partial electrical reset
condition may occur at temperatures
below 0°F (- 18°C). See “Electrical
Reset Parameter Settings” on
page 89.
Resterilization: Acceptable Unacceptable
Resterilize if the sterile package seal
is broken. Place the device in an
ethylene oxide permeable package
and resterilize with ethylene oxide.
Allow the device to aerate ethylene
oxide residues. See sterilizer
instructions for details. Use an
acceptable method for determining
sterility, such as biological indicators.
Do not implant the device if it has
been dropped on a hard surface
from a height of 12 inches (30 cm)
or more.
Do not resterilize the device or
the torque wrench using:
• an autoclave,
• gamma radiation,
• organic cleaning agents, e.g.,
alcohol, acetone, etc.,
• ultra-sonic cleaners.
Do not exceed 140
17 psi (103 kPa) when sterilizing.
Do not resterilize the device more
than twice.
Lead Evaluation and Lead Connection
■
Connector compatibility. Do not use any lead with this
pacemaker without first verifying connector compatibility.
Using incompatible leads can damage the connector or result
in a leaking or intermittent connection.
°F (60°C) or
12
Prescribing the Pacemaker
■
Pacing and sensing safety margins. Consider lead
maturation when choosing pacing amplitudes, pacing pulse
widths, and sensing levels. See “Manual Programming” on
page 42.
■
Hex wrench. Do not use a hex wrench with a blue handle or a
right- angled hex wrench. These wrenches have torque
capabilities greater than is designed for the lead connector.
See “Connection Procedure” on page 33 for lead connection
instructions.
Programming and Pacemaker Operation
■
Epicardial leads. Ventricular epicardial leads have not been
determined appropriate for use with the Capture Management
feature. Therefore, Capture Management should be
programmed Off if epicardial leads are implanted with
DR650 Series pacemakers.
K
■
Shipping values. Do not use shipping values for pacing
amplitude and sensitivity without verifying that they provide
adequate safety margins for the patient.
■
Constant current devices. To test the performance of the
lead, Medtronic recommends using a constant voltage device
such as the Medtronic Model 5311B (or equivalent) Pacing
System Analyzer (PSA). Medtronic does not recommend using
a constant current device such as the Medtronic Model 5880A
or 5375 External Pacemaker because the K
pacemakers have constant voltage output circuits.
■
Crosstalk occurs in dual chamber systems when atrial pacing
output pulses are sensed by the ventricular lead. Crosstalk
results in self-inhibition and is more likely to occur at high
sensor-driven pacing rates, high atrial amplitudes, and wide
atrial pulse widths. To prevent self-inhibition caused by
crosstalk, program Ventricular Safety Pacing (VSP) On or
lengthen the Ventricular Blanking period.
DR650 Series
13
Prescribing the Pacemaker
■
Elective Replacement Indicator (ERI). When ERI is set, the
pacemaker must be replaced within three months. See
“Elective Replacement Indicator” on page 77 for more
information.
■
Full electrical reset is indicated by VVI pacing at a rate of
65 ppm without the elective replacement indicator set. See
“Electrical Reset” on page 77 for more information.
■
Slow retrograde conduction, especially with conduction time
greater than 400 ms, may induce pacemaker-mediated
tachycardia (PMT).
■
PMT intervention. Even with the feature turned On, PMTs
may still require clinical intervention such as pacemaker
reprogramming, magnet application, drug therapy, or lead
evaluation. See “PMT Intervention” on page 67 for further
information.
■
Lead Monitor. If the Lead Monitor detects out-of-range lead
impedance, investigate lead integrity more thoroughly.
Rate Increases
■
Twiddler’s syndrome, i.e., patient manipulation of the device
after implant, may cause the pacing rate to increase
temporarily if the pacemaker is programmed to a rate
responsive mode.
■
Muscle stimulation, e.g., due to unipolar pacing, may result in
pacing at rates up to the Upper Sensor Rate in rate responsive
modes.
Unipolar Sensing
■
Continuous myopotentials cause reversion to asynchronous
operation when sensed in the refractory period. Sensing of
myopotentials is more likely when atrial sensitivity settings of
0.5 through 1.0 mV and ventricular sensitivity settings of
1.0 and 1.4 mV are programmed.
14
Prescribing the Pacemaker
Environmental and Medical Therapy Hazards
Patients should be directed to exercise reasonable caution in
avoidance of devices which generate a strong electric or magnetic
field. If the pacemaker inhibits or reverts to asynchronous operation
at the programmed pacing rate or at the magnet rate while in the
presence of electromagnetic interference (EMI), moving away from
the source or turning it off will allow the pacemaker to return to its
normal mode of operation.
Hospital and Medical Environments
■
Electrosurgical cautery could induce ventricular arrhythmias
and/or fibrillation, or may cause asynchronous or inhibited
pacemaker operation. If use of electrocautery is necessary, the
current path and ground plate should be kept as far away from
the pacemaker and leads as possible. See “Electrosurgical
Cautery” on page 47 for more information.
■
External defibrillation may damage the pacemaker or may
result in temporary and/or permanent myocardial damage at
the electrode-tissue interface as well as temporary or
permanent elevated pacing thresholds. Attempt to minimize
current flowing through the pacemaker and lead system by
following these precautions when using external defibrillation
on a pacemaker patient:
– Position defibrillation paddles as far from the pacemaker as
possible (minimum of 5 inches [13 cm]). Attempt to
minimize current flowing through the pacemaker and leads
by positioning the defibrillation paddles perpendicular to
the implanted pacemaker/lead system.
– Use the lowest clinically appropriate energy output (watt
seconds).
– Confirm pacemaker function following any defibrillation.
■
High energy radiation sources such as cobalt 60 or gamma
radiation should not be directed at the pacemaker. If a patient
requires radiation therapy in the vicinity of the pacemaker,
15
Prescribing the Pacemaker
place lead shielding over the device to prevent radiation
damage and confirm its function after treatment.
■
Lithotripsy may permanently damage the pacemaker if the
device is at the focal point of the lithotripsy beam. If lithotripsy
must be used, program the pacemaker to a single chamber
nonrate responsive mode (VVI/AAI or VOO/AOO) prior to
treatment; and keep the pacemaker at least 1 to 2 inches
(2.5 to 5 cm) away from the focal point of the lithotripsy beam.
■
Magnetic resonance imaging (MRI). Pacemaker patients
subjected to MRI should be closely monitored and
programmed parameters should be verified upon cessation of
MRI. MRI of pacemaker patients should be carefully weighed
against the potential adverse affects. Clinicians should
carefully weigh the decision to use MRI with pacemaker
patients. Limited studies of the effects of MRI on pacemakers
have shown that:
– Magnetic and radio frequency (RF) fields produced by MRI
may adversely affect the operation of the pacemaker and
may inhibit pacing output.
– Magnetic fields may activate magnet mode operation and
cause asynchronous pacing.
– Reported
1
effects of MRI on pacing include increased
ventricular pacing beyond the rate limit.
1
Holmes, Hayes, Gray, et al. The effects of magnetic resonance imaging on implantable
pulse generators. PA C E. 1986; 9 (3): 360-370.
16
Prescribing the Pacemaker
■
Radiofrequency ablation procedure in a patient with a
DR650 Series pacemaker may cause any of the following:
K
– Asynchronous pacing above or below the
programmed rate.
– Reversion to an asynchronous operation.
– Pacemaker electrical reset.
– Premature triggering of the elective replacement indicator.
RF ablation risks may be minimized by:
1. Programming a non-rate responsive, asynchronous pacing
mode prior to the RF ablation procedure.
2. Avoiding direct contact between the ablation catheter and the
implanted lead or pacemaker.
3. Positioning the ground plate so that the current pathway does
not pass through or near the pacemaker system, i.e., place the
ground plate under the patient’s buttocks or legs.
4. Having a Medtronic programmer available for temporary
pacing.
5. Having defibrillation equipment available.
Home and Occupational Environments
■
High voltage power transmission lines may generate
enough EMI to interfere with pacemaker operation if
approached too closely.
■
Communication equipment such as microwave transmitters,
linear power amplifiers, or high-power amateur transmitters
may generate enough EMI to interfere with pacemaker
operation if approached too closely.
■
Commercial electrical equipment such as arc welders,
induction furnaces, or resistance welders may generate
enough EMI to interfere with pacemaker operation if
approached too closely.
17
Prescribing the Pacemaker
■
Home appliances which are in good working order and
properly grounded do not usually produce enough EMI to
interfere with pacemaker operation. There are reports of
pacemaker disturbances caused by electric hand tools or
electric razors used directly over the pacemaker implant site.
■
Electronic article surveillance (EAS) equipment such as
retail theft prevention systems may interact with pacemakers.
Patients should be advised to walk directly through and not to
remain near an EAS system longer than is necessary.
Cellular Phones
Note: Testing was not performed on the K
to similarity in design and function to the K
data collected for the K
DR700 Series models therefore supports the
DR650 Series models due
DR700 Series models. The
safety and efficacy claims for the KDR650 Series models and is
included here for reference purposes.
DR700 Series pacemakers have been tested to the frequency
K
ranges used by the cellular phones included in Table 1. Based on this
testing, these pacemakers should not be affected by the normal
operation of such cellular phones.
These pacemakers contain a filter that allows usage, without
interaction, of all cellular phones having one of the transmission
technologies listed in Table 1. These transmission technologies
represent most of the cellular phones in use worldwide. Patients can
contact their local cellular phone service provider to confirm that the
provider uses one of these technologies.
18
Prescribing the Pacemaker
Table 1. Cellular Phone Transmission Technologies
Transmission Technology Frequency Range
Analog
FM (Frequency Modulation) 824 - 849 MHz
Digital TDMA
North American Standards
TDMA - 11 Hz 806 - 821 MHz
NADC
PCS
International Standards
GSM
DCS
a
b
(TDMA - 50 Hz)
c
1900
d
e
1800
824 - 849 MHz
1850 - 1910 MHz
880 - 915 MHz
1710 - 1785 MHz
Digital CDMA
CDMA - DS
a
Time Division Multiple Access
b
North American Digital Cellular
c
Personal Communication System
d
Global System for Mobile Communications
e
Digital Cellular System
f
Code Division Multiple Access - Direct Sequence
f
824 - 849 MHz
19
Prescribing the Pacemaker
Co-implantation with an Implantable Defibrillator
■
An implantable defibrillator may be implanted concomitantly
with a bipolar pacemaker.
– The use of unipolar-only Model KDR656 and the
DR650 Series bipolar models implanted with unipolar
K
leads is contraindicated for patients having an implantable
defibrillator.
– Follow implant protocol and precautions for pacemaker
and defibrillator lead placement. Ensure the pacemaker is
configured to be compatible with the defibrillator.
Programming Considerations
Note the following programming considerations for patients who have
an implantable defibrillator.
■
Only bipolar pacing should be used with these patients. In
some cases, pacing in the unipolar configuration may cause
the defibrillator either to deliver inappropriate therapy or to
withhold appropriate therapy.
■
Polarity is automatically configured during Implant Detection
(see “Automatic Polarity Configuration” on page 58 of the
Product Information Manual). If lead integrity is suspect,
confirmation of the automatically programmed polarities
should be made after completion of Implant Detection in order
to assure that bipolar polarities have been programmed
appropriately.
■
The implantable cardiac defibrillator (ICD) should be turned off
during pacemaker implantation procedures until lead polarities
have been configured and confirmed. This is to prevent
possible back-up unipolar paces from triggering the ICD.
■
Lead Monitor should not be programmed to Adaptive. When a
prevalence of out-of-range lead impedance paces is detected,
20
Prescribing the Pacemaker
the monitor automatically reprograms the selected lead(s) to
unipolar polarity. Pacing in the unipolar configuration may
cause the defibrillator either to provoke inappropriate therapy
or to withhold appropriate therapy.
■
Transtelephonic Monitor should be programmed to Off. If it is
programmed On, the pacing polarity is temporarily set to
unipolar when the magnet is applied. Pacing in the unipolar
configuration may cause the defibrillator either to provoke
inappropriate therapy or to withhold appropriate therapy.
■
Although these pacemakers are designed to be compatible
with implantable defibrillators, the potential does exist for a
defibrillation pulse to reset them.
– If a partial electrical reset occurs, these pacemakers
implanted with bipolar leads will retain atrial and ventricular
bipolar pacing polarities.
– If a full electrical reset occurs, these pacemakers
implanted with bipolar leads will reset to Implant Detection.
If lead integrity is suspect, confirmation of bipolar polarity
should be made after completion of Implant Detection.
21
Prescribing the Pacemaker
Adverse Events
The Medtronic Kappa 700 Series devices were evaluated in a
multicenter prospective study (43 investigational centers, 15 centers
in the US) of the adaptive features and rate response of the device.
Clinical study of the Medtronic Kappa 700 Series of pacemakers
included 288 devices implanted in 285 patients worldwide.
Note: Clinical studies were not performed on the K
series models due to similarity in design and function to the K
Series models. The clinical data collected for the K
models therefore supports the safety and efficacy claims for the
DR650 Series models and is included here for reference purposes.
K
There were a total of six deaths in the KDR700 Series study; all were
reviewed and judged to be non-device related by a clinical events
committee comprising clinical investigators and Medtronic clinical
evaluation managers. Two were attributed to ventricular arrhythmia,
one to respiratory failure, the fourth to respiratory insufficiency due to
chronic obstructive pulmonary disease, the fifth to a mesotelioma,
and the sixth to multi-system organ failure.
Eight devices were explanted: three due to pocket infection, one due
to infection of the electrode, one from lead/connector mismatch, one
patient had a psychosomatic disorder, one patient required the
implant of a dual chamber ICD, and one patient continued with
vasovagal symptoms and the therapy did not provide sufficient
benefit.
DR650 Series
DR700
DR700 Series
Observed Adverse Events
A total of 355 adverse events were reported. The device-related
events (182 events) are listed in descending order of frequency in
Ta bl e 2 .
22
Prescribing the Pacemaker
Tab le 2. Adverse Events Reported in Four or More Patients- Complicationsa
(Comps) and Observations
All patients implanted (n=288 devices in 285 patients, 133 device years)
c
% of
Patients
with
Comps
(n=285)
Event Total
Number
of
Events
(Patients)
Any adverse
355 (168) 17.2% 0.45 52% 2.22
b
(Obs)
Comps
per
Device-
Year
(n=133)
% of
Patients
with Obs
(n=285)
Obs per
Device-
Year
(n=133)
events
Any device-related
182 (118) 10.9% 0.31 34% 1.06
events
Pain at pocket site 32 (31) — — 10.9% 0.24
Other 23 (21) 1.1% 0.02 6.3% 0.15
Inappropriate
11 (11) — — 3.9% 0.08
programming
Atrial lead
11 (10) 3.6% 0.08 — —
dislodgment
Programmer/
software anomaly
11 (8) — — 2.8% 0.08
d
Pocket infection 7 (6) 0.7% 0.02 1.4% 0.03
Intermittent
6 (6) 0.7% 0.02 1.4% 0.03
undersensing
Palpitations 6 (6) — — 2.1% 0.05
Pocket hematoma 6 (6) 0.4% 0.01 1.8% 0.04
Ventricular lead
6 (6) 2.1% 0.05 — —
dislodgment
Elevated pacing
4 (4) 0.7% 0.02 0.7% 0.02
thresholds
Syncope 4 (4) — — 1.4% 0.03
23
Prescribing the Pacemaker
a
Complications included those adverse events which required invasive measures to
correct (e.g., surgical intervention), and were related to the presence of the pacing
system or procedure.
b
Observations included those adverse events which did not require invasive measures
to resolve, and were related to the presence of the pacing system or procedure.
c
Where present, a number in parentheses indicates the number of patients with the
event.
d
Programmer software anomalies observed: screen lock-ups while saving data to
diskette (8); problems printing reports outside of a patient session (2); and an incorrect
parameter setting on a printout (1), which occurred in an earlier version of the
software—software changes were made to eliminate reoccurrence.
The following other adverse events were reported, but occurred in
three or fewer patients: angina pectoris; atrial flutter (paroxysmal)/
atrial fibrillation; bipolar short circuit pathway; chest pain; chest pain
(non-specific); dizziness; dyspnea/shortness of breath; exit block;
failure to capture/loss of capture; false negative capture detection; far
field R-wave sensing; fatigue/tiredness; hypotension; inadequate
lead/pacemaker connection; infection of electrode; lead/connector
mismatch; lead insertion route problem; lead insulation failure;
migration of pulse generator; myopotential interference; other
oversensing; pacemaker mediated tachycardia; pacemaker
syndrome; pectoral muscle stimulation; penetration of myocardium
by lead; phrenic nerve/diaphragm muscle stimulation;
pneumothorax; swelling pocket site; tachycardia (atrial); thrombus
formation at lead; ventricular ectopy; ventricular tachycardia
(non-sustained); ventricular tachycardia (sustained).
The following adverse events were deemed not device related
(173 events were reported): angina pectoris; atrial fibrillation; atrial
flutter (paroxysmal); atrial flutter (persistent); atrial tachycardia; chest
pain; chest pain (non-specific); congestive heart failure; dizziness;
dyspnea/shortness of breath; fatigue/tiredness; hypertension;
hypotension; insufficient cardiac output; myocardial infarction
(acute); palpitations; syncope; ventricular ectopy; ventricular
fibrillation; ventricular tachycardia (non-sustained); ventricular
tachycardia (sustained).
24
Prescribing the Pacemaker
Potential Adverse Events
Adverse events (in alphabetical order), including those reported in
Table 2, associated with pacing systems include:
■
Cardiac perforation
■
Cardiac tamponade
■
Death
■
Erosion through the skin
■
Hematoma/seroma
■
Infection
■
Myopotential sensing
■
Nerve and muscle stimulation
■
Rejection phenomena (local tissue reaction, fibrotic tissue
formation, pulse generator migration)
■
Threshold elevation
■
Transvenous lead-related thrombosis
Clinical Studies
The Medtronic Kappa 700 Series devices were evaluated in a
multicenter prospective study (43 investigational centers, 15 centers
in the US) of the adaptive features and rate response of the device.
Note: Clinical studies were not performed on the K
models due to similarity in design and function to the K
models. The clinical data collected for the K
therefore supports the safety and efficacy claims for the K
series models and is included here for reference purposes.
DR650 series
DR700 series
DR700 series models
DR650
25
Prescribing the Pacemaker
Methods
This study compared the following features of the Medtronic Kappa
700 Series pacemakers to historical controls:
■
Rate Response
■
Capture Management
■
Automatic Polarity Configuration
■
Sensing Assurance
Patient data were collected at implant, pre-discharge, two weeks,
one month, two and/or three months, and six months post implant.
Patients were evaluated utilizing a modified version of the Minnesota
Pacemaker Response Exercise Protocol (MPREP
1
) at their one
month visit. Evaluation of rate response performance for the
Medtronic Kappa 700 Series pacemaker was conducted using the
Metabolic Chronotropic model described by Wilkoff as applied by
2
. Automatic polarity configuration data were collected at implant.
Kay
Sensing Assurance and Capture Management data were collected at
each follow-up.
Description of Patients
Patients enrolled in the study represented a general dual chamber
pacing population.
Results of the Study
Table 3 summarizes the results of the clinical study. The incidence of
complications was found to be similar to that experienced by similar
devices. The performance of the automatic polarity configuration,
Capture Management, Sensing Assurance, and rate response
features were found to meet study objectives.
1
Benditt, David G. M, Editor, Rate Adaptive Pacing, Blackwell Scientific Publications,
Boston. 1993: 63-65.
2
Kay, Neal G., “Quantitation of Chronotropic Response: Comparison of Methods for
Rate-Modulating Permanent Pacemakers”, JACC 20(7):1533-41, Dec 1992.
26
Prescribing the Pacemaker
The slope of the exercise rate response (1.0 target slope) was less
than 0.65 for 26 of 87 (30%) of patients.
All patients implanted (n=288 devices in 285 patients, 133 device years)
Primary Objectives
Automatic Polarity Configuration (n with loss of output / N leads)
Total Leads 0% (0/546) [0%, 0.55%] ≤5%
Unipolar 0% (0/107) [0%, 2.8%] ≤5%
Bipolar 0% (0/439) [0%, 0.7%] ≤5%
Sensing Assurance
(n with loss of sensing or oversensing / N device years)
Atrial 13.5% (18/133) [8.8%, 20.5%] ≤35.7%
Ventricular 0.8% (1/133) [0.2%, 4.1%] ≤9.2%
Capture Management (n with all causes loss of capture / N device years)
Loss of capture 5.3% (7/133) [2.6%, 10.5%] ≤10.7%
Slope of MPREP rate response at 1 month (n=87 patients)
Mean 0.81 [0.76, 0.86] [0.65, 1.35]
Table 3. Effectiveness Analysis
Percent of
events
% (n/N)
95%
Confidence
interval
Criteria:
Upper
95% CI
27
Prescribing the Pacemaker
The Medtronic Kappa 700 Series pacemaker’s Rate Profile
Optimization (RPO) governs sensor indicated rate (SIR) output. This
function is identical in the K
DR650 Series pacemakers. Figure 1
shows the SIR vs. the Wilkoff predicted heart rate achieved using the
RPO feature during the MPREP tests at 1 month.
All patients reaching Anaerobic Threshold, N=87
Expected (Wilkoff) rate, mean and 95% CI
100
90
80
70
CI
60
50
40
30
SIR (normalized)
20
10
0
0 204060
%
5
9
r
pe
p
U
n
a
e
M
Lower 95% CI
E
N
(
R
I
S
W
(
d
e
t
c
e
p
x
)
7
8
=
80
MPREP Workload (normalized)
Figure 1. Sensor Indicated Rate (SIR) vs. Expected Rate at One Month
R
I
S
)
f
f
o
k
l
i
100
28
Implanting the Pacemaker
Chapter 2 - Implanting the Pacemaker
Implantation Procedures 30
Implant Documentation 39
Parameter Programming at Implant 40
Medical Therapy Interactions 45
Assistance 48
29
Implanting the Pacemaker
Implantation Procedures
Testing Leads and Pacemaker
Equipment to Test the Pacemaker and Lead
To test the performance of the lead, Medtronic recommends using a
constant voltage device such as the Medtronic Model 5311B (or
equivalent) Pacing System Analyzer (PSA).
Caution: Do not use constant current devices (such as the
Medtronic external pacemaker Models 5880A, 5375, 5348, or 5346)
to test lead performance. They may damage the pacemaker’s
constant voltage output circuits.
For further procedures on determining thresholds and analyzing
pacemaker operation, consult the PSA technical manual.
Note: Wait at least 15 minutes after implanting screw-in leads
(nonsteroid) before measuring final stimulation thresholds and
intracardiac sensing potentials.
Determining Stimulation Threshold
While testing the lead system prior to implant, Medtronic
recommends taking and verifying threshold measurements in both
the unipolar and bipolar polarities for all of the pacemaker models.
Stimulation thresholds less than 1.0 V at a 0.5 ms pulse width are
recommended for acute ventricular leads. Atrial leads may have
slightly higher stimulation thresholds.
Test for the following configurations:
■
Lead tip to case (for unipolar pacing and sensing).
■
Lead tip to lead ring (for bipolar pacing and sensing).
If the stimulation threshold of a mature chronic lead exceeds 2.5 V at
a pulse width of 0.5 ms, consider replacing the lead.
Note: Low-profile 3.2 mm bipolar and IS-1 BI leads can be
connected to the pacemaker in only one way, i.e., distal (tip)
30
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