16,300 pacemaker implants in France affected by faulty Abbott devices

By Shweta Desai

PARIS (AA) - Some 16,300 heart patients in France implanted with pacemakers could be affected due to a manufacturing defect in the Abbott brand device, a national health and safety watchdog announced Thursday.

In a statement, the National Agency for the Safety of Medicines and Health Products (ANSM) said the American firm informed it about a manufacturing problem in certain models of Abbott-St. Jude Medical double chamber (Assurity and Endurity) pacemakers leading to a “water tightness defect.”

These faulty devices -- certain serial numbers of model PM2272 for the Assurity Range and of model PM2172 for the Endurity Range -- can cause “loss of cardiac pacing, reduced battery life, the device to enter pacing backup mode, and/or loss of communication capabilities with the pacemaker.” At least 50 faulty pacemakers, so far, have been reported to the health authorities.

Between September 2019 and July 2022, 16,300 pacemakers were implanted among cardiac patients in France who could be affected by the faulty models, it said. The firm has assured those patients who received implants before Sept. 1, 2019 are not affected.

The watchdog has advised concerned patients to undergo medical consultation at the health establishments to assess whether the pacemaker needs to be replaced. It has also asked patients to verify the serial number of pacemakers on the Abbott website.