Failures in Abbott brand pacemakers, implanted in more than 16,000 French patients

 Failures on certain Abbott brand pacemakers have been reported, warns the French drug agency, ANSM, on Thursday. In France, 16,300 patients are carriers. They will be contacted by their surgeon or cardiologist.


Failures linked to a manufacturing problem have been reported on certain pacemakers from the Abbott laboratory, the French drug authority announced on Wednesday. The ANSM indicates that 16,300 French patients carry these devices. According to franceinfo, around fifty pacemakers implanted in France could be affected. 


About 500,000 French people wear a pacemaker, of different brands, and about 70,000 pacemakers are implanted each year in France.



A leak 

It was Abbott that informed the ANSM "of a manufacturing problem leading in rare cases to a leak in some of its dual-chamber implantable pacemakers (pacemakers), Assurity and Enduring models manufactured and distributed between September 2019 and April 2022,” the agency said in a statement. The manufacturer has "already recalled the pacemakers that had not been implanted and the specific manufacturing process at the origin of the problem is no longer used", also specified the ANSM.


Loss of stimulation, dead battery, no connection: the possible effects

The manufacturing issue may "for example cause loss of cardiac pacing, reduced battery life, the device to enter pacing backup mode, and/or loss of communication capabilities with the pacemaker ( by telemetry in consultation and by remote monitoring at the patient's home)", detailed the ANSM. But the pacemakers are not likely to suddenly stop working, the agency told franceinfo.


How do you know if you are affected? 

The affected models are the Assurity and Enduring dual-chamber models from Abbott/St. Jude Medical. For the Assurity Range, these are some serial numbers of the PM2272 model, and for the Enduring Range, some serial numbers of the PM2172 model.


To find out if they are affected, Abbott pacemaker wearers can check the manufacturer's website by entering the seven-digit serial number found on their pacemaker wearer card. Patients implanted before September 1, 2019 with the affected models from Abbott or with a pacemaker from another brand are not affected.


For the patients concerned, the establishment where their pacemaker was implanted will "contact them soon, if they have not already done so, to organize a medical consultation", but they can also contact them directly, according to the ANSM. . The cardiologist will assess whether or not the pacemaker needs to be replaced.


In the event of symptoms such as a slow heart rate, dizziness, vertigo, loss of consciousness, or other unusual symptoms, the doctor or service in charge of the follow-up should be contacted quickly.


Patients already contacted and taken care of 

Warned in the middle of the summer, the health agency has since informed and exchanged with the representatives of the patients and the health professionals concerned. "Patients have already been contacted and taken care of by the centers which had implanted the pacemakers in question," Thierry Sirdey, director of medical devices at ANSM, told AFP.