Consumers and health professionals are advised that Boston Scientific, in consultation with the TGA, has issued hazard alerts and recalls for product correction for various models of cardiac resynchronisation therapy (CRT) devices, pacemakers (CRT-Ps) and defibrillators (CRT-Ds).
All of the affected products are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms. They can be reprogrammed using external controllers.
Boston Scientific has advised that two separate programming issues can potentially affect the different types of devices. This can lead to issues such as irregular pacing or the device becoming stuck in a safety mode, requiring replacement. Software updates offering permanent solutions to the issues are being developed, but in the meantime cardiologists are being advised of ways to change the settings of the devices to eliminate the risks.
Of the 60,500 CRT devices distributed worldwide, Boston Scientific estimates approximately 300 of them are programmed with a combination of parameters which may lead to the problematic device behaviour. There have been two confirmed instances of early device replacement due to the programming issue. Of the two cases, one patient death occurred overseas due to complications related to the replacement procedure.
Of the issues identified in pacemakers, the risk of patient injury is very low, with the highest risk (a one in 2000 probability of injury at five years) involving one particular combination of pacemaker device and electrical leads in combination with a specific device setting. Other commonly used combinations of the device and different leads have probable risks that are far lower.
The affected devices are:
| Model | ARTG number |
|---|---|
| Valitude CRT-P Model U128 | 279333 |
| Visionist CRT-P Models U225, U226, U228 | 279330, 279331, 279332 |
| Accolade Pacemakers Models L310, L311, L331 | 280319, 280315, 280316 |
| Proponent Pacemakers Models L210, L211, L231 | 280320, 280317, 280318 |
| Valitude CRT-P Model U128 | 279333 |
| Resonate CRT-D Model G447 | 296562 |
| Momentum CRT-D Model G124, G125, G126, G128 | 296563, 296564, 296565, 296566 |
| Autogen CRT-D Models G172, G173, G175, G177, G179 | 221615, 221616, 221617, 221618, 221633 |
| Visionist CRT-P Models U225, U226, U228 | 279330, 279331, 279332 |
| Dynagen CRT-D Models G151, G156, G158 | 221620, 221621, 221622 |
Information for consumers
Boston Scientific has contacted cardiologists and surgeons who have implanted potentially affected devices, providing further information about the above issues.
If you or someone you provide care for has a Boston Scientific device implanted, your cardiologist will discuss this issue with you.
New software for these devices is being developed and will resolve the issues identified. In the meantime your cardiologist can change the settings of affected devices to reduce or eliminate the risks.
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, please be aware of this issue. Reassure your patients that the issues identified are rare.
If they have any questions or concerns about this issue, refer them to their cardiologist.
Information for cardiologists
Boston Scientific has contacted cardiologists who have implanted potentially affected devices, providing detailed information about the above issues including instructions on appropriate actions to minimise any risks.
If you have not been contacted, or if you have any questions or concerns, telephone Boston Scientific on +61 2 8063 8299 or email aptechservice@bsci.com.
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.