BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 24680253 · Received March 24, 2026

    Report

    Report Number
    3006630150-2026-01752
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    July 11, 2025
    Report Date
    May 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    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 SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50. SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7160128. 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: 7160128. 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 WAS EXPERIENCING INADEQUATE STIMULATION AND OVERSTIMULATION FROM THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND SPINAL CORD STIMULATOR (SCS) LEADS WERE REPLACED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125074 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 783447 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention