Pacemaker manufacturer Abbott-St. Jude Medical warns of a leak in one of their devices: more than 16,300 French men and women are concerned.
A leak detected on Abbott-St. Jude Medical. It is the American manufacturer who warned the French authorities, and for good reason, more than 16,300 people subject to heart problems have been implanted with this equipment in recent years in the country. This defect linked to a manufacturing process now rejected by the brand puts the wearers of the models concerned at risk of serious malfunctions: reduction of cardiac stimulation, switching to emergency mode, shortened battery life, even in certain cases. rare, the complete and sudden shutdown of the device.
The affected devices are dual-chamber pacemakers from Abbott-St. Jude Medical, certain serial numbers of model PM2272, and for the Endurity line, certain serial numbers of model PM2172. About fifty faulty pacemakers have already been reported to the French health authorities.
Models established for more than 18 months
If you have a pacemaker and want to know if you are one of those affected, don’t panic: first know that if this is the case, you will very soon be contacted directly by the health establishment who installed the equipment. It is then a cardiologist who will decide on a case-by-case basis whether to remove it.
In case of doubt, wearers can directly check whether their model is concerned on the manufacturer’s website, or by directly contacting their reference health establishment. The National Agency for the Safety of Medicines (ANSM) and Products recommends paying attention to certain signs “a slow heartbeat, dizziness, vertigo, loss of consciousness (syncope) or any other unusual symptom”.
The models affected by the failure have been manufactured and distributed between September 2019 and April 2022, and implemented since September 1, 2019 internationally. The manufacturer has assured the ANSM that all the faulty equipment has been in patients implanted for at least 18 months.