BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1358043 · Received March 3, 2009

    Report

    Report Number
    3004209178-2009-01486
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 5, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZM
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    WHEN THE PATIENT LAID DOWN, SHE STARTED TO FEEL AN OVERSTIMULATION SENSATION AND STIMULATION IN THE WRONG LOCATION. SHE FELT PAIN IN HER VAGINAL AREA AND THOUGHT THERE WAS A "LIGHT" IN THE VAGINAL AREA AS WELL. THE DEVICE WAS TURNED OFF, BUT THE PAIN DID NOT RESOLVE. IT WAS NOTED THAT THE PATIENT WORKS IN JANITORIAL AND DOES A LOT OF BENDING AND HEAVY LIFTING. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V182832.| PROGRAMMER: MODEL 3037, LOT# NJD079538N.| PROGRAMMER: MODEL 3037| LEAD: MODEL 3093| EXPLANTED:| IMPLANTED: