InSync III cardiac resynchronisation therapy pacemakers

Hazard alert - potential battery issues

18 November 2015

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is issuing a hazard alert for three models of InSync III cardiac resynchronisation therapy pacemakers (CRT-P). The affected model numbers are 8042, 8042B and 8042U.

InSync III CRT-P are implantable medical devices 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 there is a very small chance that affected models of InSync III CRT-P may experience potential battery failures.

If this occurs, affected patients may experience a return of the underlying heart condition.

To 27 October 2015, there have been 30 confirmed cases of this issue worldwide, including one report of patient death where this problem may have been a contributing factor (although a direct link has not been confirmed).

InSync III CRT-P are no longer supplied and records indicate no devices have been implanted in Australia since 2011. All current Medtronic CRT-P devices supplied in Australia are not susceptible to this issue.

Information for consumers

If you or someone you care for has a pacemaker implanted check your patient identification card to see if you have an affected model of InSync III CRT-P.

Even if you have an affected model, there is only a very small chance that you might experience the above problem.

However, if you experience symptoms associated with the underlying heart condition, including lightheadedness or fainting, seek medical attention immediately.

If you have any questions or concerns regarding this issue, please contact your cardiologist.

Information for all health professionals

If you are treating a patient who has had an affected model of InSync III CRT-P implanted, advise them of this issue. Reassure them that there is only a very small chance that they might experience the above problem.

However, advise them to seek medical attention immediately if they experience symptoms associated with the underlying heart condition.

If they have any further questions or concerns about the above issue, refer them to their cardiologist.

Information for cardiologists

The battery issues described above are caused by unexpected high battery impedance.

If you are treating a patient who has had an affected model of InSync III CRT-P implanted, advise them of this issue. Reassure them that there is only a very small chance that they might experience the above problem.

However, advise them to seek medical attention immediately if they experience symptoms associated with the underlying heart condition.

Prophylactic device replacement in non-pacemaker-dependent patients is not recommended at this time.

For pacemaker-dependent patients, you should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis.

To 27 October 2015, this problem has affected only 0.03% of InSync III CRT-P implanted worldwide. Modelling by Medtronic estimates the failure rate will be between 0.16% and 0.6% for the remaining active devices. There is no provocative testing that can predict which devices may fail and there is no programming that can mitigate this issue.

Continue routine patient follow-up in accordance with standard practice, and advise patients to seek medical attention immediately if they experience new or unexpected symptoms.

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.