India's apex drug regulator Central Drugs Standard Control Organisation (CDSCO) has issued an alert about battery depletion issues in some pacemakers sold by the US-based medical device manufacturer Medtronic.
The alert was issued by CDSCO after the US Food and Drug Administration (FDA) flagged the issue earlier this month. The US FDA safety alert which CDSCO mentioned in its communication asked providers and patients to check for premature battery depletion in certain Medtronic pacemakers and asked patients to seek immediate medical care if they feel lightheaded, dizzy, chest pain or severe shortness of breath.
Loss of consciousness may also be a sign of the device's sudden battery depletion or drainage, the alert said. Medtronic said that it received three complaints out of approximately 266,700 devices distributed worldwide since February 2017, but no patient issues have so far been reported in India.
"This is not a case of a product recall and we are in proactive discussion with Central Drugs Standard Control Organisation (CDSCO)," Medtronic India said in a statement. The world's largest medical device maker earlier 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 (CRT-P).
"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," Medtronic said. In India, Astra pacemaker, Solara CRT-P and Serena CRT-P are available.
"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," Medtronic India said.