CDSCO issues alert on Medtronic’s pacemakers, company says no product recall

The CDSCO has advised patients with specific pacemakers from Medtronic to seek immediate medical assistance if they feel dizzy, light-headed, severe short breath or loss of consciousness. Meanwhile, the company has said it is in talks with the regulator


New Delhi: India’s top drug regulator has issued an alert over the three pacemakers from Medtronic, one of the leading medical technology companies globally. The move is reportedly based on the alarm raised by the US Food and Drug Administration (USFDA) on 7th May over the use of the pacemaker models Astra, Serena and Solara.

The Central Drug Standards Control Organisation (CDSCO) has asked the patients with implants of these three Medtronic pacemaker models to seek immediate medical care if they feel light-headed, dizzy or experience chest pain and loss of consciousness, saying these could be signs of the devices’ sudden battery depletion. This could mean serious trouble for patients.

The US-FDA found that in few cases Medtronic implantable pacemaker or CRT-P battery had fully drained because of a crack in the device’s capacitor, without any warning to the patient or health care provider. If a capacitor in a CRT-P is cracked, it can create an electric short, which can cause the battery to drain earlier than expected.

In its defense, the Medtronic issued a press note on 21st May citing a performance note it has published about a rare mode in a population of Azure and Astra pacemakers and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers.

The company said it received three complaints out of 2,66,700 devices distributed worldwide since February 2017. The projected rate of occurrence for this issue, as per the company, is 0.0028 percent, with the most susceptible period being the first 12 months after a device is implanted.

The statement from the company explained its stand: In consultation with our Independent Physician Quality Panel, we do not recommend device replacement and advise 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, Medtronic has implemented additional process and component enhancements that have been reviewed and approved by FDA.”

Medtronic said that the products, Astra pacemaker, Solara CRT-P and Serena CRT-P are available in India and it will 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,” the statement mentioned.

As per the company, there has been no product recall from its side and it is engaged in a proactive discussion with the regulator. “At Medtronic, we take any quality concerns with the 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,” concluded its statement.