BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 25062351 · Received May 1, 2026

    Report

    Report Number
    3006630150-2026-02835
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 1, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED APPROXIMATELY ON THE DATE OF EXPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7110293, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2352-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7074241, MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 70 CM, UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-4318, SERIAL NUMBER: NA, BATCH/LOT NUMBER: 27571336, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE DUE TO HIGH IMPEDANCE AND THE NEED FOR A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375311 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 546680 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention