Month: <span>August 2022</span>

Month: August 2022

FDA class 1 recall of medical device: the most serious type of recall

Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports of devices with a short circuit protection (SCP) alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy. A reduced-energy electrical shock may fail to correct an …

Decommission of eSUSAR by MHRA

The MHRA is retiring the eSUSAR website in favour for Individual Case Safety Reports (ICSR) Submissions, providing users “a more robust, stringent, and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products” (IMPs). The eSUSAR website used for the submission of …

error: Content is protected !!