BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 23461806 · Received November 4, 2025

    Report

    Report Number
    3006630150-2025-09965
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7160765/7160775, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43160, MODEL: SC-4316, BATCH: 35056977, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMALL SECTION OF THE INCISION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE OPENED. THE PHYSICIAN BELIEVED THAT IT WAS NOT RELATED TO THE DEVICE. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701916 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 782272 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention