Health product recall

Wavewriter Alpha Implantable Pulse Generator Kit

Last updated

Summary

Product
Wavewriter Alpha Implantable Pulse Generator Kit
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Wavewriter Alpha Implantable Pulse Generator Kit

More than 10 numbers, contact manufacturer.

SC-1232

Wavewriter Alpha 16 Implantable Pulse Generator Kit

More than 10 numbers, contact manufacturer.

SC-1216

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Boston Scientific Neuromodulation Corporation

25155 Rye Canyon Loop, Valencia, California, United States, 91355

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75920

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