BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1170713 · Received September 16, 2008

    Report

    Report Number
    3004209178-2008-05771
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 1, 2007
    Report Date
    August 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. SHE FELL ON HER DEVICE A YEAR AGO AND HER SYMPTOMS HAVE CHANGED; NOW, IT IS NOT REALLY WORKING RIGHT. FURTHER INFO 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 29 YR EXTENSION: MODEL 3095| PROGRAMMER: MODEL 3031A| EXPLANTED| LEAD: MODEL 3093| EXPLANTED