Medtronic recommends physicians to continue patient follow-up with pacemakers despite safety alerts

Following Central Drugs Standard Control Organisation (CDSCO) having red-flagged three brands of pacemakers from US medical-device maker Medtronic and United States Food and Drug Administration (FDA) also issuing safety alert on the heart implants, Medtronic has advised physicians to continue normal patient follow-up with the pacemakers 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 in a release stated..

A safety alert was also issued by the US FDA on these heart implants over concerns that their batteries drain out with no warning to the patient.

The release further states, Medtronic has published a performance note about a rare mode in a population of Azure and Astra pacemakers and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers. We 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 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, the release clarified.

In India, Astra pacemaker, Solara CRT-P and Serena CRT-P are available. The company release further said, “We have 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 and we are in proactive discussion with CDSCO. 

The safety alert on specific Medtronic pacemakers, as opposed to a product recall, comes at a time when the med-tech industry has been calling for a separate law that treats medical devices as different from drugs.

Currently, medical devices come under the Drugs and Cosmetics Act.

The CDSCO’s safety alert over the weekend to medical professionals and patients echoed US FDA observations on specific Medtronic implantable pacemakers whose batteries had drained completely because of a crack in the device’s capacitor, without any warning to the patient or healthcare manager.

“If a capacitor in an implanted pacemaker or CRT-P is cracked, it can create an electric short, which can cause a battery to drain earlier than expected,” the CDSCO said.

The three Medtronic brands named by the CDSCO were: Astra Pacemakers, Serena and Solara Cardiac Resynchronisation Therapy – Pacemakers (CRT-P).

Reports suggest that over 1,500 of these devices have been sold in India.

An implantable pacemaker or CRT-P provides pacing for slow heart rhythms and heart failure and are implanted under the skin in the chest area with connecting insulated wires or leads that go into the heart.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=115907&sid=1