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Cognis Cardiac Resynchronisation Therapy Defibrillator and Teligen Implantable Cardioverter Defibrillator - Update
Hazard alert - potential battery issue, additional models affected
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). This statement updates a previous safety alert, which the TGA published on 3 September 2013. It has been identified that additional models may experience premature battery depletion. Boston Scientific is also undertaking a recall for product correction to update software.
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.
This potential problem only affects devices that were manufactured before March 2010 with the below model numbers.
|Device family||Model numbers|
|Cognis CRT-D||N106, N107, N108, N118, N119, N120, P106, P107 and P108|
|Teligen DR ICD||E110, E111, F110 and F111|
|Teligen VR ICD||E102, E103, F102 and F103|
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. Boston Scientific is updating the software to improve the effectiveness of these tools.
For this reason, patients with affected models are advised to schedule a visit with their cardiologist as soon as possible, but within three months, to upgrade their device's software.
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.
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.
Schedule a visit with your cardiologist as soon as possible, but within three months, to have the software in your device upgraded to improve the effectiveness of these tools. Once your device has been upgraded, continue normal monitoring as directed within the device instructions and promptly investigate all alerts and beeping sounds, seeking medical attention when necessary.
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 they are 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.
However, patients with an affected device should be advised to schedule a visit with their cardiologist as soon as possible, but within three months, to upgrade their device's software.
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 March 2010 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 schedule a visit as soon as possible, but within three months, to upgrade their device's software using the updated programmer software (Model 2868, version 3.04) to improve Safety Architecture effectiveness. Once the device has been upgraded, resume normal monitoring as described in device labelling.
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.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.