A nationwide alert will be announced by the Central Drugs Standard Control Organisation (CDSCO) on Monday on some faulty pacemakers models sold by the world’s largest medical device manufacturer, Medtronic.
Confirming this, the Drug Controller General of India (DCGI) Dr. S. Eswara Reddy, said on Sunday, “The alert was approved on May 17 and will be issued this Monday.”
Medtronic’s Astra, Serena and Solara CRT-Ps (Cardiac Resynchronisation Therapy Pacemakers) have been covered under the Indian medical device alert. The two-page alert, a copy of which The Hindu has accessed, states that, according to the company, healthcare providers were unable to communicate with the device due to battery depletion, resulting in loss of pacemaker function.
