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WaveWriter Alpha recallZ-2617-2024 · Boston Scientific Neuromodulation Corporation · initiated Jul 17, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Neuromodulation Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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].

Recall details

Recall number
Z-2617-2024
Status
Open, Classified
Initiated by the company
Jul 17, 2024
Posted by the FDA
Aug 14, 2024
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
77,674
Product code
LGW
FDA submissions
P030017
Distribution
Worldwide 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

Product description

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

Code information (models, lots, serial numbers)

REF/UDI-DI(GTIN)/Serial Number Range/Expiration Date Range: M365SC12160/8714729985082/100188 - 758920, M365SC12320/8714729985099/100635 - 759404

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

92 devices cleared under P030017 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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