Advisory against Pacemaker malfunction; India’s drug controller on awareness mission

May 19, 2019:

On Saturday, India’s drug controller 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 or cardiac resynchronization therapy pacemakers (CRT-P) 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. Pacemakers and CTR-Ps are both implanted under the skin in the upper chest area with connecting insulated wires called leads that go into the heart.

If a capacitator in an implanted pacemaker is cracked, it can create an electric short that can cause a battery to drain earlier than expected.

“We issued the advisory to warn people concerned against the reported malfunction,” said Dr S Eswara Reddy, drugs controller general of India.

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.

Doctors too are being watchful. “We will be keeping an eye during follow ups,” says Dr KK Talwar, chairman, cardiology, Max Super Speciality Hospital.