BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1191807 · Received October 1, 2008

    Report

    Report Number
    3004209178-2008-06257
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 2, 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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. SHE FELT STIMULATION IN THE WRONG LOCATION AND THE DEVICE SEEMED TO HAVE MOVED OUT OF ITS POCKET. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    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 53 YR LEAD: MODEL 3093| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037| EXPLANTED:| IMPLANTED: