At Medtronic, we take any quality concerns with utmost seriousness, and the safety of patients is our primary concern. We will continue to develop high-quality therapies that positively impact lives. As technologies evolve, we continue to strive for the highest quality through enhanced systems, processes and products.
We have published a Performance Note about a rare mode in a population of some pacemakers and cardiac resynchronization therapy pacemakers. While in India we have received no (0) complaints, worldwide Medtronic has received three (3) complaints out of ~266,700 devices distributed worldwide since February 2017. The projected rate of occurrence for this issue is 0.0028 percent, with the most susceptible period being the first 12 months after a device is implanted.
These devices continue to perform well within reliability projections. In consultation with our Independent Physician Quality Panel, we do not recommend device replacement and recommend physicians (subject to the medical condition of the patient) to continue normal patient follow-up in accordance with standard practice and, where possible, to continue with remote monitoring.
In India, the Astra pacemaker, Solara CRT-P, and Serena CRT-P devices are available. We have been and continue to communicate proactively with the doctors and relevant stakeholders in India and have informed them about the performance note. There have been no patient issues reported in India related to this performance note.
Please note that this is not a case of a product recall.
If you have been implanted with these brand of pacemakers and want to know more please contact Response Care on 1800-419-6700