BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 21492952 · Received February 28, 2025

    Report

    Report Number
    3006630150-2025-01088
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    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: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6). BATCH: 7142676/7145553.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE INCISION SITE. SYMPTOMS OF PUSS AND TENDERNESS AT THE INCISION SITE WERE NOTED. THE PHYSICIAN BELIEVED INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED AND DUE TO PATIENTS CARE OR CLEANLINESS OF PATIENT. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND ALL EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285439 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 752067

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention