Stressing that it was “not a case of product recall”, Medtronic India said, “We are in proactive discussion with CDSCO”.
New Delhi: In contrast to the alert raised by the Central Drugs Standard Control Organisation (CDSCO) over the performance of pacemakers developed by Medtronic, the US device maker has recently said that it is not recalling its pacemaker models in the country. The company further mentions that it is in discussion with relevant stakeholders, reports PTI.
Medical Dialogues had earlier reported that accounting for the safety efficacy, India’s apex drug regulator Central Drugs Standard Control Organisation (CDSCO) had issued an advisory for patients and health care providers against three models of pacemakers sold by the world’s largest medical device manufacturer, Medtronic.
CDSCO has alerted patients with implants of three Medtronic pacemaker models to seek immediate medical care if they feel certain symptoms that could be signs of the devices’ sudden battery depletion.
Medtronic sells in India, Astra pacemaker, Solara CRT-P and Serena CRT-P.
“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,” the statement by the company said.
Stressing that it was “not a case of product recall”, Medtronic India said, “We are in proactive discussion with CDSCO”, reports PTI.
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,” the statement said.
In consultation with company’s 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,” 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 with any of the three models to seek immediate medical care if they feel light-headed, dizzy or experience chest pain and loss of consciousness.
The alert by the regulator came after the US Food and Drug Administration raised alarm over the use of the pacemaker models Astra, Serena and Solara.
In its alert on May 7, the USFDA cited a case in which a Medtronic implantable pacemaker or CRT-P battery had fully drained because of a crack in the device’s capacitor, without any warning to the patient or health care provider.
Medtronic’s implantable pacemakers or cardiac resynchronization therapy pacemaker (CRT-Ps) are devices that provide pacing for slow heart rhythms and heart failure pacemakers and CRT-Ps are both implanted under the skin in the upper chest area with connecting insulated wires called leads that go into the heart.
As per the alert by CDSCO, doctors have been recommended to be alert and consider whether elective device replacement is warranted for a pacemaker patient.
“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,” the alert stated.