The alert mentions three of the five models flagged by US FDA — Astra, Serena CRT-P and Solara CRT-P. Medtronic highlights it received three complaints out of ~266,700 devices worldwide since February 2017
The Central Drugs Standard Control Organisation issued an alert to healthcare providers, heart patients and medical device distributors on measures that have been taken to prevent safety issues with three models of Medtronic’s pacemakers. The alert came a week after the US Food and Drug Administration (US FDA) flagged five models of Medtronic’s pacemakers and cardiac resynchronisation therapy pacemakers (CRT-P) for battery related issues. In one such case, it led to the death of a patient, according to the regulator.
The alert mentions three of the five models flagged by US FDA that are used in India — Astra, Serena CRT-P and Solara CRT-P. In India, Astra pacemaker, Solara CRT-P and Serena CRT-P are available.
Medtronic published a performance note based on the alert issued. The note stated that a rare mode in a population of Azure and Astra pacemakers and Percepta, Serena and Solara cardiac resynchronisation therapy pacemakers have received three complaints out of ~266,700 devices distributed worldwide since February 2017. The projected rate of occurrence for this issue is 0.0028 per cent, with the most susceptible period being the first 12 months after a device is implanted. In consultation with Independent Physician Quality Panel, Medtronic does not recommend device replacement, and advises physicians to continue normal patient follow-up in accordance with standard practice and, where possible, to continue with remote monitoring. While the devices continue to perform well within reliability projections as per Medtronic’s performance note. Medtronic has also implemented additional process and component enhancements that have been reviewed and approved by FDA. There have been no patient issues reported in India related to this performance note.
They emphasised that this is not a case of a product recall and they are in a proactive discussion with CDSCO.