Failing Abbott pacemakers: models, 16,300 French people concerned

In a communicated updated on September 8, 2022, the National Medicines Agency (ANSM) informs of a manufacturing issue on pacemakers produced by Abbott/St Jude Medical “leading in rare cases to a leak”. The models concerned are Assurance and Endurance. They were manufactured and distributed in France between September 2019 and April 2022 and possibly implanted between September 2019 and July 2022 : 16,300 pacemakers are affected. “The patients implanted before 1^er September 2019 with Assurity and Endurity models or with a pacemaker from another brand are not affected“ specifies the ANSM. Abbott has already recalled pacemakers that were not implanted “and the specific manufacturing process causing the problem is no longer used”.

What are the risks ?

This manufacturing problem can for example cause:

• loss of cardiac pacing,
• a reduced battery life,
• switching the device to backup pacing mode
• and/or loss of pacemaker communication capabilities (telemetry/telemonitoring).

the failure rate observed to date is 0.15%. According to materiovigilance data in France, the reporting frequency reporting failures potentially related to the manufacturing issue is approximately 0.3% on 1^er September 2022. Based on data provided by Abbott, as of 1^er September 2022, devices confirmed as failing have been in patients implanted for more than 18 months.

What are the failing pacemaker models?

Only some dual chamber pacemakers of the brand Abbott/St. Jude Medical and Assurity and Endurity lines implanted between September 2019 and July 2022 may be affected by this issue:

• For the Assurity Range: certain serial numbers of the model PM2272
• For the Endurity Range: certain serial numbers of the model PM2172

Potentially affected patients can look at their pacemaker card or booklet and check:

• The name of the manufacturer: Abbott and/or St. Jude
• The model : either Assurity and/or PM2272 or Endurity and/or PM2172
• The 7-digit serial number.

If you do not have a pacemaker card/booklet and you were implanted between September 2019 and July 2022, you can directly contact the healthcare facility that carried out the fitting of my pacemaker.

Then go to the Abbott’s website and enter “2272” or “2172” in the “Model #: PM“, and the 7-digit serial number in the box “SERIAL #“.

• If your pacemaker is not one of the affected devices, it is written in black : “Based on the model number and serial number entered, this device is NOT subject to the 2022 Zenex, Assurity, and Endurity pacemaker laser adhesion safety notification.”
• Whether your pacemaker is affected by the problem, it is written in blue : “Based on the model number and serial number entered, this device IS subject to the 2022 Zenex, Assurity, and Endurity pacemaker laser adhesion safety notification.”

What to do ?

The patients concerned are contacted by the healthcare facility that implanted the pacemaker to arrange a medical consultation. They can also contact him directly. During this consultation, the cardiologist will assess whether or not the pacemaker needs to be replaced.

► If symptoms such as slow heartbeat, dizziness, lightheadedness, fainting (syncope) or any other unusual symptom, quickly contact the doctor in charge of your follow-up, or his department.

► Patients monitored by remote monitoring must scrupulously respect the recommendations of the medical profession (doctors, nurses, etc.), so that any alerts can be transmitted quickly to allow early and most appropriate treatment. It is important to keep the appointments scheduled for pacemaker checks, even if you are monitored by remote monitoring.

► It is possible to contact the ANSM by completing the contact form available from the page: https://ansm.sante.fr/contact.

Source: Manufacturing issue with some Abbott/St. Jude Medical double chamber (Assurity and Endurity): recommendations for patients and healthcare professionals. ANSM. 09/08/2022