16,300 French people affected by Abbott pacemaker failures

There are 16,300 French carriers of pacemakers who must be contacted by their surgeon because of a failure of certain cardiac pacemakers of the Abbott brand, alert Thursday the National Agency for the Safety of Medicines and Health Products (ANSM). It was the American manufacturer who warned the French authorities.

These Abbott-St. Jude Medical double chamber (Assurity and Endurity) have a watertightness defect. They are very rarely likely to suddenly stop working, reassures the Medicines Safety Agency, but faulty pacemakers can reduce cardiac stimulation, go into rescue mode, or battery life can be shortened. The patients concerned will be contacted by the health establishments that carried out the installation. A cardiologist will then decide whether to remove this device.

In France, around fifty faulty pacemakers have already been reported to the health authorities. They were manufactured and distributed between September 2019 and April 2022 and implanted since September 1, 2019. The manufacturer has indicated to ANSM that the devices confirmed as defective have been in patients implanted for more than 18 months.

Dual-chamber stimulators from Abbott/St. Jude Medical concerned by this failure are: for the Assurity Range, certain serial numbers of the model PM2272, and for the Endurity Range, some model serial numbers PM2172.

Patients implanted before September 1, 2019 with Assurity and Endurity models from Abbott-St. Jude Medical or carriers of a pacemaker from another brand are not affected, adds the ANSM.