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U.S. Department of Health and Human Services

Class 2 Device Recall WAVEWRITER ALPHA 16 IPG KIT, WAVEWRITER ALPHA 32 IPG KIT

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 Class 2 Device Recall WAVEWRITER ALPHA 16 IPG KIT, WAVEWRITER ALPHA 32 IPG KITsee related information
Date Initiated by FirmJuly 17, 2024
Date PostedAugust 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2617-2024
Recall Event ID 94995
PMA NumberP030017 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
ProductWAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Code Information REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365SC12160/8714729985082/100188 - 758920, M365SC12320/8714729985099/100635 - 759404
Recalling Firm/
Manufacturer		 Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information ContactRebecca KinKead Rubio
651-581-0761
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Software design
ActionOn 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 BSCFieldActionCenter@bsci.com Any adverse events or quality concerns associated with use of this product should be reported to the firm via email at BSN.ComplaintCallCenter@bsci.com 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: bsn.tech.support@bsci.com.
Quantity in Commerce77,674
DistributionWorldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, CO, CT, ID, AR, OK, MA, MI, ND, NE, SD, WV, NV, HI, NH, DC, MT, ME, VT, WY, DE, NM. OUS (foreign) countries of: Canada, Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Portugal, Japan, Australia, New Zealand, Singapore, Argentina, Brazil, Colombia, Puerto Rico
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LGW
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