The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Consulta CRT-P [Model no.: C3TR01 & Serial no.: PZI614815S], manufactured by Medtronic.
The manufacturer recently identified an issue with a subset of Consulta CRT-P devices during production. This issue was identified as a result of an internal investigation that indicated a recent trend of increasing manufacturing rejects related to the weld of a connector bracket. An out-of-specification weld could result in a loss of device hermeticity and compromised device functionality.
The manufacturer is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. Furthermore, the manufacturer advises patients implanted with Consulta CRT-P device to continue to be followed regularly in accordance with product labelling.
For details, please visit the following TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2013-RN-00572-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Jun 2013