St Jude ICDs and CRT-Ds - various models
Hazard alert - risk of premature battery depletion
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 devices and model numbers are:
|CD1235-40||Fortify ST VR|
|CD1259-40||Fortify Assura VR|
|CD1359-40||Fortify Assura VR|
|CD2235-40||Fortify ST DR|
|CD2259-40||Fortify Assura DR|
|CD2359-40||Fortify Assura DR|
|CD3255-40||Unify Quadra MP|
|CD3371-40||Quadra Assura MP|
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.
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.