DRUG CONTROLLER ISSUES ADVISORY AGAINST PACEMAKER MALFUNCTION

THE HINDUSTAN TIMES,19 MAY 2019-India’s drug controller on Saturday issued an advisory for patients and health care providers against Medtronic’s Astra pacemakers after a US Food and Drug Administration (FDA) alert about a battery-related malfunction in the device on May 7.

As per the FDA alert, three medical device reports in USA, in which a Medtronic implantable pacemaker battery had fully drained because of a crack in the device’s capacitator, without any warning to the patients or health care providers.

Implantable pacemakers or CRT-P are devices that provide pacing for slow heart rhythms and heart failure.

According to officials 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 reported in the USA within one year after patients were implanted with the pacemaker. They were reported on average within seven months of the device getting implanted.

The advisory informs that those involved should be aware of sudden battery levels drop during follow up visits. Patients must watch out for signs such as feeling lightheaded, dizzy, chest pain, severe shortness of breath.