India’s drug controller on weekday issued an informative for patients and health care providers against Medtronic’s Astra pacemakers after a United States Food and Drug Administration (FDA) alert about a battery-related malfunction within the device on May 7.
As per the agency alert, 3 medical device reports in the USA, within which a Medtronic implantable pacemaker or cardiac resynchronization therapy pacemakers (CRT-P) battery had totally drained due to a crack within the device’s capacitator, without any warning to the patients or health care providers.
Implantable pacemakers or CRT-P are devices that offer to pace for slow heart rhythms and heart failure. Pacemakers and CTR-Ps are both ingrained beneath the skin within the upper chest area with connecting insulated wires known as leads that go into the heart. If a capacitator in an ingrained pacemaker is cracked, it will produce an electrical short that can cause the battery to drain earlier than expected.
“We issued the informative to warn individuals involved against the reportable malfunction,” aforesaid Dr. S Eswara Reddy, medicine controller general of India. According to the officers in the Union health ministry, as on date, 1,850 such devices have been imported to India, of which 1,600 have been sold.
The adverse events were reportable within the USA within one year after patients were ingrained with the pacemaker. They were reportable on the average within seven months of the device obtaining ingrained.
The informative informs that those concerned ought to remember of sudden battery levels drop throughout follow up visits. Patients should be careful for signs like feeling lightheaded, dizzy, chest pain, severe shortness of breath.
Doctors too are being watchful. “We are going to be keeping an eye fixed throughout follow-ups,” says Dr. KK Talwar, chairman, cardiology, Max Super Speciality Hospital.