India’s drug regulator warns patients against defective Medtronic pacemakers

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The Indian drug regulator has alerted patients with implants of three Medtronic pacemaker models to seek instant medical care whether they feel light-headed, dizzy or experience chest pain and loss of consciousness, saying these could be signs of the devices’ sudden battery depletion.


The alert by Central Drug Standards Keep watch over Organisation (CDSCO) came after the USA Food and Drug Administration (USFDA) raised alarm over the usage 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 as a result of a crack in the device’s capacitor, without any warning to the patient or health care provider.


Whether a capacitor in a CRT-P is cracked, it can create an electric short, which can cause the battery to drain earlier than expected.


Medtronic’s implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) are devices that supply 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.


India’s CDSCO has advised patients to seek instant medical assistance whether they feel dizzy, light-headed, severe short breath or loss of consciousness.


“These could also be signs that your device’s battery has had a sudden drop or has drained,” it said.


Doctors have been advisable to be alert and believe if elective device replacement is warranted for a pacemaker patient.


“Take note of sudden battery level drops all over 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 although the level remains inside the normal range,” the alert stated.


Medtronic reported that healthcare providers were unable to convey with the device because of battery depletion resulting in loss of pacemaker operate. It also reported these events occurred in the USA inside one year after the patient used to be implanted with the pacemaker or CRT-P.


Probably the most reported events resulted in the death of a pacemaker-dependent patient.


In another reported incident, the patient experienced dizziness all over follow-up and the healthcare provider used to be unable to convey with the device, which resulted in the patient getting their device replaced.


In the third event, there used to be no harm to the patient because the device used to be not implanted when the healthcare provider became aware that a connection with the device could not be established.

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