Abbott Safety Notification Regarding a Subset of Assurity and Endurity Pacemakers
March 19, 2021 - Abbott announced a safety notification that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 have experienced moisture ingress into the header of the pacemaker pulse generator causing a percentage of devices to malfunction. HRS is working together with Abbott and the Food and Drug Administration on this communication to ensure our members have the latest, accurate information.
Publication Date: March 19, 2021
On March 15, 2021, Abbott announced a safety notification that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 have experienced moisture ingress into the header of the pacemaker pulse generator causing a percentage of devices to malfunction. HRS is working together with Abbott and the Food and Drug Administration on this communication to ensure our members have the latest, accurate information.
Moisture entering the device header can affect a subset of the following pacemaker models;
PM1152, PM1160, PM1172, PM1240, PM1272, PM2152, PM2160, PM2172, PM2240, PM2260, PM2272.
Although affected devices are no longer available for implantation, Abbott estimates that there are currently approximately 95,000 active devices worldwide impacted by this issue, of which approximately 65,000 are in U.S. patients. There have been 135 devices returned, all of which underwent analysis, and found to have abnormalities in the pulse generator header which could allow moisture ingress.
Devices with this issue have been reported to exhibit a variety of device behaviors;
- Loss of telemetry (both remote monitoring and in-person device interrogation)
- Loss of pacing
- Reduced battery life
- Shortened time span between elective replacement indication (ERI) and end of service (EOS), (with an average of 17 days and a minimum reported of 2 days)
At one manufacturing site, there was infrequent, intermittent and incomplete mixing of the epoxy applied to the pulse generator header during the manufacturing process. This can result in moisture or fluid entering the pulse generator header.
Abbott Recommends the Following
- Enroll patients in Merlin.net and follow patients via remote monitoring. Of note, ERI and EOS alerts are monitored daily.
- Continue routine follow up where battery voltage and overall pacemaker function can be assessed.
- Perform prompt generator replacement for any device exhibiting abnormal device behavior or that has reached ERI or EOS unexpectedly.
- Abbott, in consultation with their Medical Advisory Board, recommends against prophylactic device replacement given the mitigation of remote monitoring and the risks associated with device replacement.
An Abbott webpage will be available by the end of March in order to query potentially affected devices by serial number.
Adverse reactions or quality problems experienced with the use of this product should be reported to Abbott and to the FDA MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit a report online at www.fda.gov/medwatch/report.htm.
- Call 1-800-332-1088 to request a reporting form or download from www.fda.gov/MedWatch/getforms.htm. Forms may be mailed or faxed. Follow instructions on form.
For additional questions, contact your local Abbott Representative or Abbott Technical Services at 1-800-722-3774.