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Wavewriter Alpha Implantable Pulse Generator Kit — recall 75920

Health Canada — Medical Devices · Canada · 2024-08-14 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75920
Date of alert
2024-08-14
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/wavewriter-alpha-implantable-p

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