Australia’s Therapeutic Goods Administration (TGA) reports that Medtronic Australasia issued a hazard alert on July 15, 2013 regarding its Consulta Cardiac Resynchronization Therapy Pacemaker. This implantable medical device is used to treat heart failure. The alert warns of a manufacturing issue affecting a subset of Medtronic’s particular pacemaker model (Consulta CRT-P C3TR01) made between April 1st and May 13th 2013. The issue “could compromise the sealing of the device”, leading to a “loss of pacing output”, which in turn could result in fainting, shortness of breath, fatigue, swelling, and other symptoms.
Australia’s TGA has a similar function to the U.S. Food and Drug Administration.
Sources: Therapeutic Goods Administration, https://www.tga.gov.au/alert/consulta-cardiac-resynchronization-therapy-pacemaker