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Dr Gérald Kierzek (Medical Director)
The ANSM (National Agency for the Safety of Medicines and Health Products) has been informed by Abbott/St. Jude Medical that some of its pacemakers have a manufacturing problem. 16,300 wearers would be concerned in France.
What products are affected?
The risk of a failure occurring is indicated on certain Abbott brand implantable pacemakers:
- Assurity “dual chamber” pacemakers (model PM 2272)
- Endurity dual-chamber pacemakers (model PM2172)
In France, this alert concerns approximately 16,300 devices manufactured and distributed between September 2019 and April 2022 and possibly implanted between September 2019 and July 2022. The press release recalls that patients implanted before 1er September 2019 with the Assurity and Endurity models from Abbott/St. Jude Medical or carriers of a pacemaker from another brand are not affected by this alert.
In addition, a recall of devices not yet implanted was carried out by the manufacturer in July 2022.
What are the risks involved?
According to the Abbott company, a manufacturing problem would lead to “in rare cases” to a leak in some of its pacemakers, which could lead to “loss of pacing, reduced battery life, device going into backup pacing mode, and/or loss of pacemaker communication capabilities”. Based on the data provided, the devices confirmed as failing were in patients implanted for more than 18 months.
Do you think you are one of the French people affected by this alert? Two solutions are available to you:
- If you have a Pacemaker Wearer’s Card or Booklet, please verify the manufacturer’s name (Abbott and/or St. Jude), model, and 7-digit serial number. On the Abbott website directly : enter your model and serial number, a result written in black indicates a device not concerned, a result written in blue indicates a device concerned by the report.
- Or contact directly the establishment which carried out the installation of your pacemaker.
What if the report concerns you?
If you have not already done so, the healthcare facility that implanted your pacemaker should contact you to arrange a medical consultation, or even consider replacing your device. You can also contact him directly.
In case of symptoms such as slow heart rate, dizziness, dizziness, contact the doctor in charge of your follow-up. If you are followed by remote monitoring, scrupulously respect the recommendations of the medical profession, reminds the agency.