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Wavewriter alpha implantable pulse generator kit
Official notice
14 Aug 2024
An official Health Canada notice concerns Wavewriter alpha implantable pulse generator kit. Boston Scientific has received reports of undesired sensation and/or awareness of IPG turning off and on during IPG charging for patients with rechargeable SCS IPGs. Investigation of these reports determined that the device may reset (by design) due to detection of noise or interference during IPG charging. When the system resets, the patient's programmed stimulation turns off for approximately 10-15 seconds and then turns back on. When this occurs, some patients may perceive the sudden changes in stimulation. As soon as the reset is complete, the IPG resumes normal operation, including delivery of stimulation therapy. Boston Scientific has identified improvements (including an IPG firmware update for implanted devices) that will prevent this device reset behavior from occurring during IPG charging. Updating the IPG firmware eliminates the possibility of a coincident routine system check during IPG charging, thus preventing a potential system reset. This firmware update is available for any rechargeable SCS IPGs identified. Recall Start Date: July 17, 2024 Published 2024-08-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75920
Official notice
2024-08-14
The hazard
The hazard
Boston Scientific has received reports of undesired sensation and/or awareness of IPG turning off and on during IPG charging for patients with rechargeable SCS IPGs. Investigation of these reports determined that the device may reset (by design) due to detection of noise or interference during IPG charging. When the system resets, the patient's programmed stimulation turns off for approximately 10-15 seconds and then turns back on. When this occurs, some patients may perceive the sudden changes in stimulation. As soon as the reset is complete, the IPG resumes normal operation, including delivery of stimulation therapy. Boston Scientific has identified improvements (including an IPG firmware update for implanted devices) that will prevent this device reset behavior from occurring during IPG charging. Updating the IPG firmware eliminates the possibility of a coincident routine system check during IPG charging, thus preventing a potential system reset. This firmware update is available for any rechargeable SCS IPGs identified. Recall Start Date: July 17, 2024
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How to check if you're affected
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Brand: Boston Scientific Neuromodulation, Wavewriter Alpha Implantable Pulse Generator Kit.
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