Failures linked to a manufacturing problem have been reported on certain pacemakers from the Abbott laboratory, the French drug authority announced on Wednesday, September 7, giving the action to be taken for patients potentially concerned 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 implantable pacemakersdouble chamber, Assurity and Endurity models manufactured and distributed between September 2019 and April 2022 »announced the ANSM in a press release.
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%.
“Loss of cardiac stimulation”
The manufacturing problem may “for example, causing loss of cardiac pacing, reduced battery life, device switching to backup pacing mode, and/or loss of communication capabilities with the pacemaker (via telemetry in consultation and by telemonitoring in the patient’s home)”she detailed.
The manufacturer has “already recalled pacemakers that had not been implanted and the specific manufacturing process causing the issue is no longer in use”also specified the ANSM.
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 in them”said Thierry Sirdey, director of medical devices at ANSM.
The patients concerned have already been contacted or will be contacted soon.
“For the fastest and most appropriate care possible for the patients concerned, in view of the potential risk”the health agency has drawn up recommendations for wearers of these pacemakers and, in conjunction with learned societies, for health professionals.
Patients implanted before September 1, 2019 with the affected models from Abbott or with a pacemaker from another brand are not affected. To find out if they are, wearers of certain Abbott pacemakers can check on the manufacturer’s website by entering the seven-digit serial number found on their pacemaker wearer card.
For affected patients, the facility where their pacemaker was implanted will “contact soon, if he has not already done so, to arrange a medical consultation”but they can also contact him directly, according to the ANSM, in particular in the event of symptoms such as a slow heartbeat, dizziness, vertigo, loss of consciousness or other unusual symptom.