BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 24674173 · Received March 24, 2026

    Report

    Report Number
    3006630150-2026-01755
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    September 1, 2024
    Report Date
    May 12, 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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FALL OF 2024 PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. BLOCK D6B: EXPLANT DATE: 2024 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7132143 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7137382. MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND OCCASIONAL SHOCK LIKE SENSATIONS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333613 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 585448 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Required Intervention