BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1172979 · Received September 19, 2008

    Report

    Report Number
    3004209178-2008-05962
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS AT 5.2 FOR AMPLITUDE AND IT WAS PERFECT. SHE STARTED LIFTING HAND WIGHTS AND SHE HAD TO CHANGE THE AMPLITUDE SETTING. OVER A WEEK AGO SHE DECREASED THE SETTINGS AND NOTICED A RETURN OF SYMPTOMS. THE PATIENT MOVED THE AMPLITUDE TO VARIOUS LOCATIONS AND IT STILL DID NOT WORK. THE PATIENT WAS ABLE TO MOVE THE AMPLITUDE BACK UP TO 5.1 WITHOUT DISCOMFORT. 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 58 YR EXPLANTED:| LEAD: MODEL 3889| PROGRAMMER: MODEL 3037| IMPLANTED: