BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25224999 · Received May 19, 2026

    Report

    Report Number
    3006630150-2026-03301
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    October 30, 2024
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECTS MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2366-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7071180 MODEL/CATALOG DESCRIPTION: LINEAR 3-6 LEAD 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4) MODEL NUMBER/CATALOG NUMBER: SC-2366-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7071105 MODEL/CATALOG DESCRIPTION: LINEAR 3-6 LEAD 50 CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND NO PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104585 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 528021 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1