Medtronic India, manufacturer of pacemaker models in India has refuted a health regulator's alert on its pacemaker devices.
The Medtronic pacemaker devices are in radar after the Central Drugs Standard Control Organisation (CDSCO) alerted a warning. CDSCO alerted patients saying that three models of Medtronic pacemaker devices could feel certain symptoms. These could be owing to a faulty discharge of sudden battery depletion.
In India, the three models include the Astra pacemaker, Solara CRT-P and Serena CRT-P.
Medtronic on Tuesday released a note stating that it was in touch with stakeholders and refuted the angle of a major recall. "We are in proactive discussion with CDSCO," the company added.
The statement read, "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."
"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 statement added.
"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," it added.
"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 Food and Drug Administration," the statement said.
The CDSCO has asked patients using any of the three reported models to seek immediate medical care on feeling light-headed, dizzy or chest pain and loss of consciousness. "Be aware of sudden battery level drops during follow-up visits and remote transmissions. Watch for decrease in battery level out of proportion to the life of the device from the time of implant even if the level remains within the normal range," CDSCO's alert stated.
CDSCO's alert came on the heels of a similar caution spread by the US Food and Drug Administration. The US agency in an alert on May 7, cited a case involving a Medtronic implantable pacemaker. In this case, the battery drained fully owing to a crack in the device's capacitor.