BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25032782 · Received April 29, 2026

    Report

    Report Number
    3006630150-2026-02744
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    January 1, 2024
    Report Date
    April 29, 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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080096. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM UNIQUE IDENTIFIER(UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7080169. MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM. UNIQUE IDENTIFIER(UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND UNABLE TO ENTER MAGNETIC RESONANCE IMAGING (MRI) MODE DUE TO IMPENDANCES OUT OF RANGE MESSAGE. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460409 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 581834 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1