The Central Drugs Standard Control Organisation (CDSCO) has red-flagged three brands of pacemakers from US medical-device maker Medtronic.
The development comes less than a fortnight after a similar safety alert was issued by the United States Food and Drug Administration (USFDA) on these heart implants over concerns that their batteries drain out with no warning to the patient.
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 USFDA 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 brands
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.
In a global communication on these pacemakers, Medtronic said that it had received three complaints (from over two lakh implanted pacemakers) that included “a no output /no telemetry scenario resulting from rapid battery depletion”, as on April 26.
Battery depletion due to this issue could range from several days to several weeks, the company said, adding, “One of these reported events contributed to a patient’s death. The three confirmed failures occurred within 9 months post implant.”
Responding to BusinessLine’s query, Medtronic reiterated that this was not a product recall. “We have published a Performance Note about a rare mode in a population of Azure and Astra pacemakers and Percepta, Serena and Solara cardiac resynchronisation 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,” the company said.
“There have been no patient issues reported in India related to this performance note,” it added.
Addressing patient concerns on whether they needed to go in for revision surgeries, Medtronic said: “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 the FDA.”
In India, the Astra pacemaker, the Solara CRT-P and the Serena CRT-P are available, Medtronic said, adding that it is keeping doctors and relevant stakeholders informed on developments involving these pacemakers. – Business Line