WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320

Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

On 7/17/24, "URGENT MEDICAL DEVICE ADVISORY" Notices were sent to Physicians/Surgeons, Hospitals, Healthcare Professionals informing them of the following: 1) Review any patient reports of undesired sensations indicative of potential device reset behavior during IPG charging and report these observations to Boston Scientific. 2) An in-field IPG firmware update is available for the patient s device. This will eliminate the possibility of a coincident routine device system check during IPG charging, thus preventing a potential system reset. Append the patients medical record accordingly if a firmware update is completed. 3) Patient letter is enclosed with this communication. This letter is provided for sharing with your patient and/or to be included within the patient s medical record. The patient letter can also be accessed on the Boston Scientific Product Advisories page via this link: www.bostonscientific.com/en-US/pprc/product-advisories.html 4) Post this information in a visible location near the product(s) to ensure information is easily accessible to all users. 5) Distributor customers should notify all customers that have been shipped/sold affected product about the correction. 6) Complete and return the acknowledgement form to [email protected] Any adverse events or quality concerns associated with use of this product should be reported to the firm via email at [email protected] The patient letter advises the following: discuss this letter and the device software update with your doctor and continue to follow their instructions. If you have any additional questions after contacting your doctor, please contact the firm's Support at 1-833-327-8324 (Option 2) or email to: [email protected].