Performance Notes
Dual Chamber Pacemakers with Measurement Lock-up ERI

Dual Chamber Pacemakers with Measurement Lock-up ERI

View specific models that this applies to

Kappa 600/700/800/900. EnPulse, Adapta, Versa, Sensia, Relia, and Vitatron Models E50A1, E60A1 and G70A1

Purpose of this Information

This Performance Note describes a rare measurement lock-up issue that impacts the Medtronic dual chamber pacemakers listed above. If this measurement lock-up occurs, the device will trigger a false Elective Replacement Indicator (ERI). A reset is available to clear this condition and there is no need to explant the device. This issue does not impact battery longevity.

Background

If this rare measurement lock-up occurs in the pacemaker, it causes the device to read a value of zero for battery voltage. After four measurements of zero, the device will trigger ERI and revert to a VVI pacing mode at 65 bpm. There is no loss of ventricular pacing and the output voltage will remain the same.

Programmer Software Reset Method (Adapta, Versa, Sensia, Relia, Vitatron Series E and G)

Programmer software is available which can differentiate a regular ERI and an ERI caused by the measurement lock-up issue. Upon interrogation of a device with the measurement lock-up ERI, the programmer software recognizes the issue and guides the clinician to clear the ERI (Example 1). Following an ERI reset, the device parameters should be reviewed and reprogrammed to clinician specifications.

Reset Method for Kappa and EnPulse

A service tool continues to be available through Medtronic Technical Services to clear the measurement lock-up issue for Kappa and EnPulse devices.

The issue can be identified using the programmer or via CareLink transmission; the battery voltage measurements and remaining longevity will appear as blank values (Example 2). If this measurement lock-up occurs, contact Medtronic Brady Technical Services at 1-800-505-4636 for assistance.


Example 1 – Programmer Software Detects Measurement Lock-up ERI Example 2 – Programmer Screens for Measurement Lock-up ERI (Kappa and EnPulse)

Meas Lock ERI Example 1 Image 1

 

Meas Lock ERI Example 2 Image 1

Meas Lock ERI Example 2 Image 2

Specific Models This Applies To

ADD01 Adapta D
ADDR01 Adapta DR
ADDR03 Adapta DR
ADDR06 Adapta DR
ADDRL1 Adapta DR
ADDRS1 Adapta DR
ADVDD01 Adapta VDD
E1DR01 EnPulse DR
E1DR06 EnPulse DR
E1DR21 EnPulse DR
E2D01 EnPulse 2
E2D03 EnPulse 2
E2DR01 EnPulse 2 DR
E2DR03 EnPulse 2 DR
E2DR06 EnPulse 2 DR
E2DR21 EnPulse 2 DR
E2DR31 EnPulse 2 DR
E2DR33 EnPulse 2 DR
E2VDD01 EnPulse 2 VDD
E50A1 E50 D
E60A1 E60 DR
G70A1 G70 DR
KD700 Kappa 700 DR
KD701 Kappa 700 DR
KD703 Kappa 700 DR
KD706 Kappa 700 DR
KD901 Kappa 900 D
KD903 Kappa 900 D
KD906 Kappa 900 D
KDR600 Kappa 600 DR
KDR601 Kappa 600 DR
KDR603 Kappa 600 DR
KDR606 Kappa 600 DR
KDR651 Kappa 600 DR
KDR653 Kappa 600 DR
KDR700 Kappa 700 DR
KDR701 Kappa 700 DR
KDR703 Kappa 700 DR
KDR706 Kappa 700 DR
KDR720 Kappa 700 DR
KDR721 Kappa 700 DR
KDR730 Kappa 700 DR
KDR731 Kappa 700 DR
KDR733 Kappa 700 DR
KDR801 Kappa 800 DR
KDR803 Kappa 800 DR
KDR806 Kappa 800 DR
KDR901 Kappa 900 DR
KDR903 Kappa 900 DR
KDR906 Kappa 900 DR
KDR921 Kappa 900 DR
KDR931 Kappa 900 DR
KDR933 Kappa 900 DR
KVDD700 Kappa 700 VDD
KVDD701 Kappa 700 VDD
KVDD901 Kappa 900 VDD
RED01 Relia D
REDR01 Relia DR
REVDD01 Relia VDD
SED01 Sensia D
SEDR01 Sensia DR
SEDRL1 Sensia DR
VEDR01 Versa DR
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