BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14681714 · Received June 13, 2022

    Report

    Report Number
    3006630150-2022-02841
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 18, 2022
    Report Date
    June 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SC-8336-50, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7076522.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SYMPTOMS OF INFECTION ARE FEVER AND DRAINAGE. THE PHYSICIAN ASSESSED THE INFECTION AS NOT DEVICE RELATED AND THE SUSPECTED CAUSE IS MRSA (METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS). THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PLACED ON INTRAVENOUS ANTIBIOTICS. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989774 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 529065 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention