Important Safety Alerts

Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its ASSURITY and ENDURITY pacemakers [Models: PM1152, PM1160, PM1172, PM1240, PM1272, PM2152, PM2160, PM2172, PM2240, PM2260, PM2272].

The manufacturer is informing customers of an issue which may affect a subset of ASSURITY and ENDURITY pacemakers. Through its post market surveillance processes, an observed rate (0.049%) of malfunctions has been detected among devices manufactured between 2015 and 2018. A subset of approximately 95,000 devices within the referenced timeframe are potentially susceptible to this issue.

According to the manufacturer, the issue is caused by intermittent incomplete mixing of epoxy during manufacture, which may allow moisture ingress into the pulse generator header. Reported clinical impact included loss of telemetry /communication, reduced battery longevity, loss of pacing, and/or shortened duration between Elective Replacement Indicator (ERI) and End of Service (EOS).

The manufacturer recommends the following actions to affected users:

1. Prophylactic generator replacement is not recommended
2. Routine follow-up should remain as per standard of care and clinical protocol
3. Prompt replacement for devices that reach ERI or EOS unexpectedly or experience one of the reported clinical impacts mentioned above
4. If possible, monitor patients using its patient care network, Merlin.net, to benefit from alert monitoring between routine device checks.

According to the local supplier, the products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary action.

Posted on 16 March 2021