BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1083603 · Received July 29, 2008

    Report

    Report Number
    3004209178-2008-04487
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD ACUTE PAIN, LOSS OF THERAPEUTIC EFFECT AND COULD FEEL WIRES ON HER SPINE SHE NEVER FELT BEFORE. THE PT THOUGHT THE LEADS HAD MIGRATED. THESE SYMPTOMS STARTED A COUPLE OF WEEKS AFTER LIFTING A HEAVY OBJECT AND INCREASED EXERCISE INTENSITY. THE PT IS AT HOME AND IN FAIR CONDITION. SHE HAS BEEN REDIRECTED TO HER HEALTHCARE PROFESSIONAL. FURTHER INFO IS BEING REQUESTED FROM HER HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER MODEL 3031A LOT#NGM012545P| EXPLANTED| LEAD MODEL #3093 LOT#J0406154V| IMPLANTED| PROGRAMMER MODEL #3031A