CDSCO issues device alert on 3 Medtronic pacemakers
India’s apex drug regulator has issued an alert to healthcare providers, heart patients and medical device distributors on measures they have to take to prevent safety issues with three models of Medtronic’s pacemakers. The Central Drugs Standard Control Organisation (CDSCO) alert on Saturday comes over a week after the US Food and Drug Administration (US FDA) flagged five such models of Medtronic’s pacemakers and cardiac resynchronisation therapy pacemakers (CRT-P) for issues related to their batteries. In one such case, the issue led to the death of a patient, according to the regulator.

However, no adverse events have been reported in India so far, according to the Indian arm of the US medical device giant.

CDSCO’s alert mentions three of the five models flagged by US FDA that are used in India — Astra, Serena CRT-P and Solara CRT-P.

Read more: https://indianexpress.com/article/business/companies/after-us-fda-cdsco-issues-device-alert-on-3-medtronic-pacemakers-5735462/
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