The world’s largest medical device manufacturer, Medtronic, appears to have decided to remain silent and continue selling its allegedly defective pacemakers in India. This puts thousands of heart patients at risk of a sudden death caused by premature battery depletion in their Medtronic pacemakers.
A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. It is a life-saving device. Medtronic, Abbott, Boston Scientific and Biotronik manufacture the leading pacemaker brands in India. In India, pacemakers cost between ₹1 lakh to ₹9 lakh, with batteries that last on average between 7-10 years.
On May 7, and in January 2019, along with a similar recall in January 2018, the U.S. Food and Drug Administration (FDA) issued warnings and recalled recalled some pacemakers manufactured and sold by Medtronic in that country after problems were detected in the device. This included pacemaker models named Azure, Astra, Percepta, Serena and Solara; CRT-Ds (Cardiac Resynchronisation Therapy-Defibrillator) such as Amplia; and ICDs (implantable cardioverter defibrillators) such as Evera.
‘Never communicated’
However, this was never communicated by the company to medical professionals here, confirmed Indian doctors and senior Health Ministry officials.
“In fact, all these models are still doing brisk business in India,” said cardiologist Dr. Balbir Singh of the Medanta Mediclinic. His unit is currently dealing with at least nine patients who have returned for battery replacement, “a direct fall-out of this criminal neglect,” said Dr. Singh.
Dr. S. Eswara Reddy, Drug Controller General of India, said, “We are aware of the May 7 FDA alert on Medtronic pacemakers and its adverse effect on our patients. We have written to Medtronic asking them for details on how many of the allegedly defective products have been sold, and their position here in India. We have received a reply from them and it is being processed. We may soon come up with a public information/announcement about the problem.”
‘Not enough’
“This is just not enough,” said retired State Bank of India (SBI) employee Chander Singh, currently admitted at a super specialty private hospital in north India for the replacement of his Medtronic pacemaker. His 2015 CRT-D advanced pacemaker manufactured by Medtronic, with a promised battery life of 7 to 11 years, packed up in four years this Wednesday. The battery in the device that keeps Mr. Singh’s heart beating had drained, requiring immediate change for him to stay alive.
“Shocked and perplexed, we have no option but to get a replacement to help my father stay alive. Medtronic was informed about the faulty device but they refused to replace it or pay compensation. We will be moving court against the company for harassment and fraud after my father’s surgery,” said Sunil Kumar, Mr. Singh’s son.
‘Exploitation’
“Currently, in India, medical devices don’t come under the notified category, which basically means that devices can be imported from anywhere and used in India. This exposes our patients to abuse and exploitation,’’ said a senior Health Ministry official.
Medtronic’s apparent neglect comes close on the heels of the Johnson & Johnson faulty hip implant case, where loopholes in the Indian medical device regulatory laws were used to push sub-standard products into the country.
In a statement issued late on Friday, Medtronic said: “For Astra pacemaker, Solara CRT-P and Serena CRT-P models we are communicating proactively with the doctors and relevant stakeholders in India and have informed them about the performance note. As for the January 2019 recall while most devices are not affected, all patients with affected devices can have them non-invasively reprogrammed to a mode that will prevent a pacing pause.”
