Following the U.S. Food and Drug Administration (FDA) alert about batteries in certain Medtronic implantable pacemakers draining more quickly than expected, patients in India using the device claim that they are yet to be alerted about the issue.
The problem with the batteries in certain pacemakers has resulted in at least one death and one injury, the FDA confirmed. Senior Indian cardiologists have said they had alerted the manufactures about the ‘defect’ as early as 2017 and had informed hospital authorities.
While the exact number of these defective implants in use in India is not yet known, Dr. Balbir Singh, interventional cardiologist at Medanta-The Medcity said, “I was alerted to the problem in 2017-end after which I stopped using these pacemakers. We also immediately informed the company about the problem. However, it is only now that the FDA has issued this warning which will have a huge impact on patients in India.”
He explained that as a precautionary measure, patients with this device are being called for a check-up every three months instead of the normal six months.
The FDA said the affected Medtronic implantable pacemaker and CRT-P device models include Azure, Astra, Percepta, Serena and Solara. Some 2,66,700 devices have been distributed worldwide, with 1,31,889 in the U.S., according to the company and the FDA.