BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16858273 · Received May 3, 2023

    Report

    Report Number
    3006630150-2023-02452
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    July 14, 2022
    Report Date
    May 3, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7083265 / 7084960.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE POCKET AND MIDLINE INCISION SITES. SYMPTOMS OF INFECTION WERE FEVER AND REDNESS AT THE INCISION SITES. IT WAS ALSO NOTED THAT THE PATIENT CONTRACTED COVID-19 AND HAD ASSOCIATED SYMPTOMS. THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS HOSPITALIZED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151892 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 540557 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention