BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARI-STIM III STIMULATOR

    MDR report key: 298101 · Received September 29, 2000

    Report

    Report Number
    1045254-2000-00017
    Event Type
    Injury
    Date Received
    September 29, 2000
    Date of Event
    August 29, 2000
    Report Date
    August 31, 2000
    Manufacturer
    MEDTRONIC XOMED
    Product Code
    JXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED: "DURING PROCEDURE THE STIMULATOR DID NOT APPEAR TO FUNCTION APPROPRIATELY IN THAT ALL 3 SETTINGS SEEMED TO BARELY CAUSE A TWITCH. POST-OP VISIT TO SURGEON REVEALED NERVE INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARI-STIM III STIMULATOR * JXE MEDTRONIC XOMED NA 200773-00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention