BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12365803 · Received August 25, 2021

    Report

    Report Number
    3006630150-2021-04748
    Event Type
    Injury
    Date Received
    August 25, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7073503.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. IT WAS ALSO NOTED THAT THE INCISION OPENED UP MAKING THE IPG VISIBLE. SYMPTOMS OF INFECTION WERE FEVER AND TENDER TO TOUCH OR CHARGE. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT A SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265125 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 502809 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention