BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22572172 · Received July 22, 2025

    Report

    Report Number
    3006630150-2025-05760
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: LINEAR? 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7083254.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH SYMPTOMS OF INFLAMMATION AND SWELLING AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS HOSPITALIZED AND UNDERWENT AN EXPLANT PROCEDURE OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED BY THE MEDICAL FACILITY. POST OPERATIVELY, THERE WERE NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724643 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 787527 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention