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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00646-1
Product Name/Description	Consulta CRT-P (Implantable cardiac pacemaker) Model number: C3TR01 Serial Number: PZI614814S ARTG number: 174342
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	26/06/2013
Responsible Entity	Medtronic Australasia Pty Ltd
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. Loss of hermeticity may allow body fluids to enter the device. This has the potential to compromise functionality resulting in loss of output.
Recall Action	Hazard Alert
Recall Action Instructions	Medtronic are asking physicians to advise patients to seek medical attention immediately if they experience a return of symptoms related to bradycardia or heart failure. If considering prophylactic device replacement for pace maker dependant patients with an affected device, physicians should carefully assess individual patient circumstances against the known risk of device replacement. Physicians should continue to routinely follow up patients as per standard practice. For more details, please see http://www.tga.gov.au/safety/alerts-device-consulta-130715.htm .
Contact Information	02 9857 9053 - CRDM Product Marketing Manager