St Jude ICDs and CRT-Ds - various models

Hazard alert - risk of premature battery depletion

18 October 2016

Consumers and health professionals are advised that St Jude Medical, in consultation with the TGA, is issuing a hazard alert for various models of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) manufactured before 23 May 2015 (see 'Affected products' below).

St Jude Medical is also recalling unused stock of these products

ICDs and CRT-Ds are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms.

It has been confirmed that a very small proportion of these devices (0.21%) has developed premature battery depletion after implantation due to shorting caused by lithium cluster formation in the battery.

If this occurs, defibrillation therapy is interrupted, which can lead to serious health consequences. There are two overseas reports of deaths associated with loss of defibrillation therapy due to premature battery depletion and 10 overseas reports of serious events (fainting) that may have been linked to premature battery depletion.

Battery depletion in these cases can occur within a day to a few weeks.

Premature battery depletion can be identified by health professionals through remote monitoring or during normal follow-up appointments through the elective replacement indicator (ERI) or other signs of advanced battery depletion.

Patients will also receive a vibratory patient notifier alert if their device has reached ERI.

Affected products

Affected devices and model numbers are:

Model Trade Name
CD1233-40 Fortify VR
CD1233-40Q
CD1235-40 Fortify ST VR
CD1235-40Q
CD1259-40 Fortify Assura VR
CD1259-40Q
CD1359-40 Fortify Assura VR
CD1359-40C
CD1359-40Q
CD1359-40QC
CD2233-40 Fortify DR
CD2233-40Q
CD2235-40 Fortify ST DR
CD2235-40Q
CD2259-40 Fortify Assura DR
CD2259-40Q
CD2359-40 Fortify Assura DR
CD2359-40C
CD2359-40Q
CD2359-40QC
CD3235-40 Unify
CD3235-40Q
CD3251-40 Unify Quadra
CD3251-40Q
CD3255-40 Unify Quadra MP
CD3255-40Q
CD3261-40 Unify Assura
CD3261-40Q
CD3267-40 Quadra Assura
CD3267-40Q
CD3361-40 Unify Assura
CD3361-40C
CD3361-40Q
CD3361-40QC
CD3367-40 Quadra Assura
CD3367-40C
CD3367-40Q
CD3367-40QC
CD3371-40 Quadra Assura MP
CD3371-40C
CD3371-40Q
CD3371-40QC

Information for consumers

Please note that, at this time, the above issue has been confirmed in only a very small proportion (0.21%) of the potentially affected ICD and CRT-D devices implanted.

St Jude Medical has contacted cardiologists and surgeons who have implanted potentially affected devices, providing further information about the above issue including a patient advisory letter.

If you or someone you provide care for has one of these ICD or CRT-D devices implanted, your managing health professional will discuss this issue with you and may provide you the patient advisory letter.

In particular, your managing health professional will ensure that you can feel and recognise a vibratory patient notifier alert. If you feel a vibratory alert, contact your health professional as soon as possible.

If not already done, consider enrolling for remote monitoring, which provides a direct alert if ERI is reached.

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

Information for health professionals

If you are treating a patient who has a potentially affected device and is concerned, reassure them that this issue has been confirmed in only a very small proportion of devices implanted (0.21%). However, advise them that this issue is serious and they should ensure they are able to feel and recognise a vibratory patient notifier alert.

Patients who have felt a vibratory alert, or have any questions or concerns about this issue, should be referred to their cardiologist.

Information for cardiologists and surgeons

Do not implant unused stock of potentially affected devices.

St Jude Medical has contacted cardiologists who manage patients with potentially affected devices, providing further information about the above issue including a patient advisory letter.

If you are managing a patient who has a potentially affected device, based on your clinical judgment you should either provide them the patient advisory letter or schedule a visit to discuss this issue.

Prophylactic device replacement is not recommended. However, if ERI is reached, immediate device change is recommended.

At the patient’s next follow-up appointment, check their device to determine if an ERI alert has been triggered. Perform a patient notifier test to ensure patients can feel and recognise a vibratory patient notifier alert and understand what they should do if they experience it. Patients who cannot feel or recognise a vibratory alert could experience battery depletion and/or loss of device function without being aware of it.

Consider recommending that patients enrol for remote monitoring to avoid or minimise time without defibrillation therapy for bradycardia and tachycardia events. For patients who are currently enrolled in remote monitoring, remind them of the importance of using remote monitoring.

If you have any questions or concerns about this issue, contact St Jude Medical on 02 9936 1214 or 02 9936 1211.

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.