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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 .
Contact Information 02 9857 9053 - CRDM Product Marketing Manager