MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION WaveWriter Alpha?; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-1232
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was involved in a motor bike accident which caused the spinal cord stimulator (scs) implantable pulse generator (ipg) to be damaged.It was stated that there was no issue with the devices prior to the accident.The patient underwent a revision procedure where the ipg and scs leads were removed and replaced.The device had been turned off since the accident and battery depleted so it was not possible to see what was working and what was not therefore, both the ipg and leads were replaced.Post operatively, the patient was stable.The explanted devices will not be returned as they were disposed by the physician.
Additional Manufacturer Narrative
Additional suspect medical device component(s) involved in the event: model number/catalog number: sc-2352-70 serial number: (b)(6) batch/lot number: 7083160 model/catalog description: linear 3-4 lead 70 cm unique identifier (udi): (b)(4) model number/catalog number: sc-2352-70 serial number: (b)(6) batch/lot number: 7082873 model/catalog description: linear 3-4 lead 70 cm unique identifier (udi): (b)(4).

• Brand Name: WaveWriter Alpha?
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50936045
• Report Number: 3006630150-2026-07200
• Device Sequence Number: 21516357
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• UDI-Public: (01)08714729985099(17)260815(10)767605
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/15/2026
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 767605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male