More than 16,300 Abott implantable pacemakers are affected by a manufacturing defect in France, informs the ANSM in a press release published this Thursday, September 8. Manufactured and distributed by Abbott/St. Jude Medical between September 2019 and April 2022, these pacemakers (Assurity and Endurity models) may have been implanted in patients between September 2019 and July 2022.
These manufacturing problems can cause leak tightness. If it does not totally prevent the pacemaker from working, this defect can cause “loss of pacing, reduced battery life, device going into backup pacing mode, and/or loss of pacemaker communication capabilities“, indicates the press release of the ANSM.
Manufacturing problem on some #pacemakers Abbott/St. Jude Medical: We make recommendations for #patients and the professionals of #health
âž• Information: https://t.co/RYap87AeiS
To identify affected pacemakers pic.twitter.com/Hma9TPvNLB
—ANSM (@ansm) September 8, 2022
How do you know if you are affected?
The models affected by this defect are Abbott/St. Jude Medical of the Assurity (some of model serial number PM2272) and Endurity (some serial number of model PM2172) ranges implanted between September 2019 and July 2022. In France , about fifty pacemakers could be concerned. Every year, between 60,000 and 70,000 pacemakers are fitted in the country.
To check if you are concerned, the ANSM recommends pacemaker carriers to go to the manufacturer’s website and enter the seven-digit serial number found on the pacemaker carrier card.
All patients implanted before 1er September 2019 with the models concerned or carriers of another brand of pacemaker are not affected by this leak.
What to do if you are concerned?
If you are concerned, the health establishment in which your pacemaker was implanted will contact you (if it has not already been done) in order to organize a medical consultation. dical. If he doesn’t, you can also contact him directly. The cardiologist you meet will decide whether or not to remove your pacemaker.
In the meantime, the following symptoms should alert you and encourage you to consult a specialist as soon as possible:
- A slow heart rate,
- of the dizziness,
- or a loss of consciousness
Source :
- Manufacturing issue with certain implantable pacemakers Abott.St. Jude Medical double chamber (Assurity and Endurity): recommendations for patients and healthcare professionals, ANSM, September 8, 2022
