Failures linked to a manufacturing problem have been reported on certain pacemakers from the Abbott laboratory, the French drug authority announced on Wednesday, giving the course of action for potentially affected patients and for health professionals.
“The Abbott/St. Jude Medical has 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 Endurity models manufactured and distributed between September 2019 and April 2022,” the ANSM announced in a statement.
More than 16,000 simulators concerned
This potentially concerns around 16,300 pacemakers in France, according to the agency. At the beginning of September, the frequency of declarations reporting failures potentially linked to the manufacturing problem was around 0.3%.
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)”, she detailed.
The manufacturer has “already recalled 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.
Who is concerned ?
To find out if they are affected, wearers of certain Abbott pacemakers can check the manufacturer’s website by entering the seven-digit serial number found on their pacemaker wearer card.
For the patients concerned, the establishment where their 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 the pacemaker needs to be replaced.
In the event of symptoms such as a slow heartbeat, dizziness, vertigo, loss of consciousness or other unusual symptom, the doctor or service in charge of the follow-up should be contacted quickly. Patients implanted before September 1, 2019 with the affected models from Abbott or with a pacemaker from another brand are not affected.