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

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.

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

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

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

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

DR701, KDR721,

DR731

and K

KDR703 and

DR733

DR706 Unipolar Unipolar 5 or 6 mm

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

1992).

DR700 Series pacemakers are programmed using the Medtronic

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.

or IS-1a BI

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.

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.

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.

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.

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

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

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.

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

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.

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.

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

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.

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

(TDMA - 50 Hz)

1900

1800

824 - 849 MHz

1850 - 1910 MHz

880 - 915 MHz

1710 - 1785 MHz

Digital CDMA

CDMA - DS

Time Division Multiple Access

North American Digital Cellular

Personal Communication System

Global System for Mobile Communications

Digital Cellular System

Code Division Multiple Access - Direct Sequence

824 - 849 MHz

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.

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.

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 .

Adverse Events

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

Complications

(Comps) and Observationsb (Obs)

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

% 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

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

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

Adverse Events

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.

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.

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

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).

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

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

. 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.

) at their one

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

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

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.

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.

Clinical Studies

All patients reaching Anaerobic Threshold, N=87

Expected (Wilkoff) rate, mean and 95% CI

100

SIR (normalized)

0 204060

Lower 95% CI

)

(

MPREP Workload (normalized)

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

)

(

100

+ 110 hidden pages

Medtronic KDR706 Technical Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Table of contents

Device Description

Indications and Usage

Contraindications

Warnings and Precautions

Pacemaker Dependent Patients

Medical Therapy

Storage and Resterilization

Lead Evaluation and Lead Connection

Programming and Pacemaker Operation

Environmental and Medical Therapy Hazards

Co-implantation with an Implantable Defibrillator

Programming Considerations

Adverse Events

Observed Adverse Events

Potential Adverse Events

Clinical Studies

Methods

Description of Patients

Results of the Study