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- 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.
- 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
- 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.
- 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.
- 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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