Faults related to a manufacturing problem have been reported in certain Abbott laboratory pacemakers, the French Medicines Authority announced on Wednesday, giving the course of action for potentially affected patients and health professionals.
“Abbott/St. Jude Medical has informed the ANSM of a manufacturing problem that, in rare cases, has caused a leak in some of its dual-chamber implantable pacemakers, Assurity and Endurity models, manufactured and distributed between September 2019 and April 2022,” the ANSM announced. in a press release.
Low number of reports
This potentially affects some 16,300 pacemakers in France, according to the agency. At the moment, franceinfo underlines here, only about fifty defective pacemakers have been reported to the public authorities. At the beginning of September, the frequency of declarations with faults potentially related to the manufacturing problem hovered around 0.3%.
The manufacturing issue may “for example, cause loss of pacing, reduced battery life, the device entering pacing backup mode, and/or loss of communication capabilities with the pacemaker (via telemetry in consultation and by remote monitoring in the patient’s home). she detailed.
Recommendations issued to patients
The manufacturer “has already withdrawn the pacemakers that had not been implanted and the specific manufacturing process at the origin of the problem is no longer used,” the ANSM also specified. Alerted in mid-summer, the health agency has since informed and exchanged with patient representatives and health professionals concerned. “Patients have already been contacted and treated by the centers that implanted the pacemakers in question,” Thierry Sirdey, ANSM’s director of medical devices, told AFP.
“For the fastest and most appropriate care of affected patients, with respect to potential risk”, the health agency has developed recommendations for users of these pacemakers and, in conjunction with scientific societies, for health professionals. To find out if they are affected, users of certain Abbott pacemakers can check the manufacturer’s website by entering the seven-digit serial number found on their pacemaker user card.
500,000 pacemaker wearers in France
For affected patients, the establishment where the pacemaker was implanted “will contact them soon, if they have not already done so, to arrange a medical consultation”, but they can also contact them directly, according to the ANSM. . The cardiologist will assess whether or not it is necessary to replace the pacemaker.
In case of symptoms such as slow heartbeat, dizziness, vertigo, loss of consciousness or other unusual symptoms, the doctor or service in charge of monitoring should be contacted promptly.
Patients implanted before September 1, 2019 with the affected Abbott models or with a non-Abbott pacemaker are not affected. About 500,000 French people have pacemakers, of different brands, and about 70,000 pacemakers are implanted every year.
Source: BFM TV
