Recommended mitigations to reduce likelihood of cardioversion procedure-related damage to Percept™ PC Model B35200 Implantable Neurostimulator

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited, as a follow up to their earlier communication in December 2021, to update healthcare professionals of recommended mitigations to reduce the likelihood of cardioversion procedure-related damage to the Percept™ PC Implantable Neurostimulator (INS). Medtronic has created a protocol to create a “Cardioversion Group” that is activated prior to the cardioversion procedure. This “Cardioversion Group” will produce very low (non-therapeutic) electrical current that helps to protect the Percept™ PC INS during a cardioversion procedure. However, there is still a remote possibility for energy from a cardioversion procedure to damage the implantable device, which may require INS replacement. Therefore, it is important to confirm the device is functional following the cardioversion procedure and restore the patient’s therapy settings. Healthcare professionals are advised to refer to the instructions for ‘Cardioversion Group’ development and other recommended mitigation measures in the letter. Please refer to the letter for details. Published: 11 Apr 2022

Dear Healthcare Professional Letters