BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1232533 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07453
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S STIMULATION WAS TURNING ON AND OFF. THE PATIENT UNDERWENT REPROGRAMMING AND HAD HIS PROGRAMMER REPLACED AND WAS STILL EXPERIENCING PROBLEMS WITH THE SYSTEM. IT WAS SUGGESTED THAT "THE WIRING MAY BE IN THE WRONG PLUG"; THE OFF BUTTON WAS TURNING THE DEVICE ON. IT WAS STATED THAT THE PATIENT WILL HAVE SURGERY TO FIX THE PROBLEM. THE PATIENT OUTCOME IS UNKNOWN. FURTHER INFORMATION IS BEING REQUESTED FROM THE 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 55 YR EXPLANTED:| PROGRAMMER: MODEL 3037| IMPLANTED:| LEAD: MODEL 3093