Health professionals and consumers are advised that Medtronic Australasia, in consultation with the TGA, is issuing a hazard alert for its Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P).
Consulta CRT-P is an implantable medical device used to treat heart failure. The device provides pacing to help coordinate the heart's pumping action and improve blood flow.
It has been identified that a manufacturing issue for a subset of Consulta CRT-P model C3TR01 devices manufactured between 1 April-13 May 2013 could compromise the sealing of the device. This may allow body fluids to enter the device, which could cause it to not function properly.
If this happens, it may cause loss of pacing output, which could potentially result in return of symptoms, including:
- fainting or lightheadedness
- dyspnoea (shortness of breath)
- fatigue
- oedema (swelling).
One Consulta CRT-P device manufactured between 1 April-13 May 2013 has been implanted in Australia and there have been no reports of device failures or patient injuries relating to this issue.
Information for consumers
Medtronic Australasia has contacted the cardiologist who implanted the one affected Consulta CRT-P model C3TR01 device manufactured between 1 April-13 May 2013, providing further information regarding the above issue.
If you have a pacemaker implanted and symptoms of heart failure return seek medical attention immediately.
If you have any questions or concerns regarding this issue, contact your surgeon, cardiologist or the hospital where the surgery was undertaken.
Information for all health professionals
Patients who have had a Consulta CRT-P implanted, and who have any questions or concerns about the above issue, should be referred to their surgeon, cardiologist or the hospital where the surgery was undertaken.
Information for surgeons and cardiologists
Medtronic Australasia has contacted the cardiologist who implanted the one affected Consulta CRT-P model C3TR01 device manufactured between 1 April-13 May 2013, providing further information regarding the above issue and advice on how to treat the affected patient.
The cardiologist has been advised to continue routine follow up in accordance with their standard practice.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.