|24 September 2014||Update: Cognis Cardiac Resynchronisation Therapy Defibrillator and Teligen Implantable Cardioverter Defibrillator|
Consumers and health professionals are advised that Boston Scientific, in consultation with the TGA, has issued a hazard alert to cardiologists and surgeons regarding some models of Cognis Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Teligen Implantable Cardioverter Defibrillators (ICDs).
ICDs are implantable medical devices that use small electrical impulses to treat abnormal heart rhythms. CRT-Ds are ICDs that also coordinate the beating of the left and right ventricles to improve the heart’s blood pumping ability.
It has been identified that some Cognis CRT-Ds and Teligen ICDs may experience premature battery depletion.
Please note that Cognis CRT-Ds and Teligen ICDs contain diagnostic tools that, along with other equipment used by cardiologists, monitor the device’s performance. In all reported cases, these tools detected the battery issues before patients experienced any problems.
This potential problem only affects devices with the below model numbers that were manufactured before December 2009, which have not been available for implant since November 2010.
|Device family||Model numbers|
|Cognis CRT-D||N106, N107, N118, N119, P106 and P107|
|Teligen DR ICD||E110 and F110|
|Teligen VR ICD||E102 and F102|
On this page: Information for consumers | Information for health professionals | Information for cardiologists and surgeons | Reporting problems
Information for consumers
Boston Scientific has contacted cardiologists and surgeons who have implanted Cognis CRT-Ds and Teligen ICDs, providing further information about the above issue.
If you have a CRT-D or ICD implanted and experience any unexpected symptoms, or if you hear beeping from your implanted device, seek medical attention.
Please note that, even if you have a CRT-D or ICD that is affected by this issue, diagnostic tools within your device should detect premature battery depletion before you experience any problems.
If you have any questions or concerns regarding this issue, please contact your cardiologist, surgeon or the hospital where the surgery was performed.
Information for health professionals
If you are treating a patient who has a Cognis CRT-D or Teligen ICD implanted and is concerned about the above issue, you should reassure them that diagnostic tools within these devices should detect premature battery depletion before they experience any problems.
Patients who are experiencing unexpected symptoms or can hear beeping from their implanted device should be referred to their cardiologist, surgeon or the hospital where the surgery was performed.
Information for cardiologists and surgeons
It has been identified that affected models of Cognis CRT-Ds and Teligen ICDs manufactured before December 2009 may experience diminished low voltage capacitor performance, causing increased current drain that can lead to premature battery depletion.
Patients who have an affected device implanted should be monitored normally, as described in the device labelling.
At their next appointment, you should advise those patients that if they experience any unexpected symptoms or hear beeping from their implanted device to seek medical attention.
If this issue occurs, one or more ‘Safety Architecture’ alerts will be triggered, which will be accompanied by beeping from the implanted device. The most common alert is a yellow screen displayed on the programmer upon initial interrogation saying ‘Voltage is too low for projected remaining capacity. Contact Technical Services with Code 1003’. In other instances, this issue can result in an unanticipated ‘Explant’ (‘ERI’) battery status alert and a replacement window that may be less than three months.
Please note that the ‘Approximate time to Explant’ and ‘Time Remaining’ estimates displayed on the programmer will not be accurate after a Safety Architecture low voltage alert.
All devices that experience unanticipated alerts and replacement indicator messages should be investigated. All devices that have been identified as having diminished low voltage capacitor performance must be replaced. If not replaced, increased current drain could deplete the battery and compromise therapy and telemetry.
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.