BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1220432 · Received October 31, 2008

    Report

    Report Number
    3004209178-2008-07099
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INTERMITTENT STIMULATION WHEN HER DEVICE WAS ON. 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 EXTENSION: MODEL 3095| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3080