Consumers and health professionals are advised that St Jude Medical, in consultation with the TGA, has issued a hazard alert regarding a potential issue with its Ellipse family of implantable cardioverter defibrillators (ICDs).
St Jude Medical is also recalling unused stocks of these ICDs and replacing them with redesigned devices.
ICDs are implantable medical devices that use electrical impulses to treat abnormal heart rhythms.
It has been identified that, during capacitor maintenance or charging for high voltage therapy, a 'Capacitor Charge Time Limit reached' message may occur. The delay in charge time could result in delayed or insufficient delivery of high voltage therapy.
If a 'Capacitor Charge Time Limit reached' message occurs, the patient will experience a detectable vibratory alert. If the patient is enrolled in and uses Merlin.net, a notification will also be received through that system.
Health professionals will be able to identify any instances of the message during device interrogation with the Merlin programmer.
The models that may be affected by this issue are:
- CD1277 (-36 and -36Q)
- CD1377 (-36, -36Q, -36C and -36QC)
- CD2277 (-36 and -36Q)
- CD2377 (-36, -36Q, -36C and -36QC).
The serial numbers of affected Ellipse ICDs include:
- numbers beginning with '1' below 1132470
- numbers beginning with '7' below 7126267
- Numbers beginning with '8' - all devices.
As of 19 August 2014, there had been no reports of serious injury or death associated with this problem. No other St Jude Medical device models are affected by this issue.
Information for consumers
St Jude Medical has written to cardiologists who are treating patients who have an affected Ellipse ICD, providing further information about this issue, including advice regarding patient management.
There have been no reports of serious injury or death as a result of this problem. The likelihood of a patient experiencing delayed or insufficient therapy as a result of this anomaly is very low.
If you, or someone you care for, have an Ellipse ICD and experience a vibratory alert or a Merlin.net notification relating to a 'Capacitor Charge Time Limit reached' message, contact your treating cardiologist.
If you have any questions or concerns about this issue, contact your treating cardiologist.
Information for all health professionals
If you are treating a patient who has an Ellipse ICD and who is concerned about this issue, reassure them that there have been no reports of serious injury or death as a result of this problem and the likelihood of them experiencing delayed or insufficient therapy due to it is very low.
If a patient continues to have questions or concerns about this issue, refer them to their treating cardiologist.
Information for cardiologists
St Jude Medical has written to cardiologists who are treating patients who have an Ellipse ICD, providing further information about this issue, including advice regarding patient management.
Surgeons/cardiologists are advised not to use any affected Ellipse devices which may be on their shelves. St Jude Medical is recalling unused ICDs with the identified model and serial numbers and replacing them with redesigned devices.
If you are treating a patient who has an Ellipse ICD, advise them of this issue and instruct them to contact you if they receive a vibratory alert or a Merlin.net notification relating to a 'Capacitor Charge Time Limit reached' message.
Device replacement is not recommended for affected ICDs that are exhibiting normal charge times. In these circumstances, you should continue following-up patients according to the routine schedule.
If a 'Capacitor Charge Time Limit reached' message occurs, you should:
- schedule the patient for an in-office follow-up evaluation as soon as possible
- interrogate the ICD and perform a manual capacitor maintenance charge, noting the charge time to full charge (it should be approximately 15 seconds or less)
- contact St Jude Medical to review the results of the capacitor maintenance test and discuss if additional evaluation is required
- consider replacement for a device that experiences repeated extended charge time out warnings.
The large majority of the reported 'Capacitor Charge Time Limit reached' messages have been identified at the routine six-month automatic capacitor maintenance interval. Consider programming this interval to every four months at each patient's next follow-up visit (although this will reduce device longevity by about 9%).
If you have any questions or concerns about this issue, contact St Jude Medical.
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.