No patient complaints in India, says Medtronic

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  1. Medical device manufacturing company Medtronic has claimed that it had received no patient complaints in India after the US Food and Drug Administration (FDA) in its safety communication has alerted healthcare providers and patients about the batteries in certain Medtronic implantable pacemakers.
  2. US FDA had said that the pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) which can drain faster than expected without any warning could lead to devices losing power quickly and triggering a medical emergency
  3. After, US FDA’s communication, the Central Drugs Standard Control Organisation (CDSCO) in India had 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.
  4. Pacemakers are battery-powered devices that provide pacing for slow heart rhythms and heart failure. If a capacitor which is one of the electronic components of these devices is cracked it may lose functionality and create an electrical short which can cause rapid battery depletion.
  5. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device. It functions under the Drugs and Cosmetics Act. CDSCO comes under Directorate General of Health Services, Ministry of Health & Family Welfare.

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