BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1180992 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06189
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS HAD A LOSS OF THERAPEUTIC EFFECT WHEN HIS DEVICE WAS ON. IT STARTED AFTER A FALL. THE PATIENT WAS AT HOME IN GOOD CONDITION. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL 3093| PROGRAMMER: MODEL 3031A| EXTENSION: MODEL 3095| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED: