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Health Sciences Authority
Dear Healthcare Professional Letters

Potential failure of Model B35200 Percept PC Implantable Neurostimulator following cardioversion

Audiences

Healthcare professional

Industry member

Product type

Medical devices

8 December 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of the potential failure of the Model B35200 PerceptTM PC Implantable Neurostimulator (INS) following a cardioversion procedure. Medtronic has determined that cardioversion may damage the electronics in the PerceptTM PC INS device, making the INS unresponsive and non-functional. To restore stimulation therapy, surgical replacement of the INS will be required. Cessation of therapy will likely cause a return of disease symptoms. In some cases, symptoms may return with an intensity greater than that experienced prior to implant. In rare cases, this can constitute a medical emergency. Medtronic is updating the Information for Prescribers (IFP) manual to add warning language specific to cardioversion. Medtronic is also investigating additional mitigations and potential design changes to reduce the likelihood of cardioversion-related damage to the INS and will communicate additional information when it becomes available. Healthcare professionals are advised to communicate the warnings on cardioversion with their patients implanted with PerceptTM PC devices, and to discuss the relative benefits and risks associated with proceeding with a PerceptTM PC device with patients who are considering a new or replacement implant and who have concomitant conditions that may require cardioversion. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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