BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25123447 · Received May 8, 2026

    Report

    Report Number
    3006630150-2026-02973
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    January 1, 2025
    Report Date
    May 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2025. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5171328 / 5154302. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS FRACTURED AND HAD SEVERAL HIGH IMPEDANCES ON THE OTHER LEAD. THE PATIENT EXPERIENCED A DIFFICULTY AND FREQUENT CHARGING OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A LEAD AND IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117909 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 522188 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1