Product Information
St. Jude Medical has issued a field safety notice regarding the potential for invalid lead impedance measurement on certain pacemaker models.
The affected devices are the Accent DR dual chamber pacemaker models PM2112, PM2212, and the Anthem CRT-P models PM3112 and PM3212.
A new version of programmer software (13.2.1) is available to prevent this issue from occurring in the future.
Clinical Implications
Out-of-range PLI measurements may lead to a Merlin net alert or an initial interrogation alert message on the programmer screen.
If the lead monitoring feature is programmed to switch polarity, an internal daily lead impedance value that is out-of-range will cause the device to auto-program the lead polarity to unipolar.
The pacing and sensing functions of the device are not affected.
Rate of Occurrence
The rate of occurrence is higher in the CRT-P devices due to shorter V-V intervals, which result in a higher potential for residual charge.
There have been no serious injuries or patient deaths attributed to this issue.
RQA01660 Recommendations and Mitigations
A new programmer software version (13.2.1) is available to prevent a false reading.
The software automatically activates circuitry in the pacemaker during the interrogation process to ensure that any residual charge on the PLI measurement capacitor is discharged prior to performing the daily PLI measurement.
Ensure that the new programmer software version is loaded onto your programmers as soon as practical, and continue to follow patients on their standard follow-up schedule.
Manual:
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