Safety Notice Regarding Subset of Abbott Assurity and Endurity Pacemakers Manufactured Between 2015 and 2018

Publication Date: October 7, 2021 (Update)

Impacted Models

Models PM1152, PM1160, PM1172, PM1240, PM1272, PM2152, PM2160, PM2172, PM2240, PM2260, PM2272

Background

On March 15, 2021, Abbott announced a safety notice that some Assurity and Endurity pacemakers manufactured between 2015 and 2018 experienced moisture ingress into the header of the pacemaker pulse generator, causing a small percentage of devices to fail (initially estimated at 0.049% and now roughly at 0.07%).

The root cause was determined to be incomplete mixing of the epoxy during the manufacturing process at one manufacturing site, allowing moisture or fluid to enter the header of the generator. At that time, Abbott estimated that there were approximately 95,000 remaining active devices worldwide (approximately 65,000 in the U.S.) which were potentially susceptible to moisture ingress.

Updates

In March, there were 135 returned devices with moisture detected in the header, and since then, there have been an additional 96 devices returned. Of these 96 devices, 29 were manufactured outside of the initial timeframe of interest that demonstrated moisture ingress. Based on this additional information, Abbott has broadened the window of manufacturing dates, which expands the potentially affected population to an additional 240,000 pacemakers worldwide with an estimated failure rate of 0.01% for this cohort (approximately 164,000 in the U.S.). To date, no serious adverse events or patient deaths have been reported related to this issue.

Abbott has developed an Electronics Performance Indicator (EPI) tool which uses device data available on Merlin.net to identify abnormal device behavior related to device loss of hermeticity. The EPI tool's estimated sensitivity is 87%, and its estimated specificity is 99.9%. The tool is expected to detect the abnormal device function roughly 6 weeks prior to loss of device functionality. If a patient with a potentially affected device is having difficulty connecting to Merlin.net with their home monitor, the patient's record can be manually imported into the Merlin.net Patient Care Network in a healthcare setting (i.e., device clinic) allowing the EPI tool to analyze that patient's device data. If the EPI tool detects abnormal device behavior, Abbott will notify the respective device c linic team using the email contact information in Merlin.net.

Possible Device Behavior

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 11.5 days and a minimum reported of <1 day)