| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00572-1 |
| Product Name/Description |
Medtronic Consulta CRT-P (Implantable cardiac pacemaker)
Model number: C3TR01
Serial number: PZI614815S
ARTG number: 174342 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic 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. |
| Recall Action |
Recall |
| Recall Action Instructions |
Medtronic is requiring the return of non-implanted devices manufactured between April 1 and May 13, 2013 for re-inspection. Currently there are currently no specific patient management recommendations for implanted Consulta CRT-P device patients. Patients should continue to be followed regularly in accordance with product labelling. This issue continues to be evaluated and any changes in patient recommendations by Medtronic’s Independent Physician Quality Panel will be immediately communicated to implanting surgeons after consultation with TGA. For futher details, please see http://www.tga.gov.au/safety/alerts-device-consulta-130715.htm |
| Contact Information |
02 8274 1399 - Medtronic Australasia |