BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM SCREENER

    MDR report key: 1200065 · Received October 15, 2008

    Report

    Report Number
    2182207-2008-06570
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TRIAL, THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION WHILE BENDING OR GOING UP THE STAIRS. THE PT WENT ON TO GET A STIMULATOR PERMANENTLY IMPLANTED. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM SCREENER EZW MEDTRONIC NEUROMODULATION 3625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female EXPLANTED:| LEAD: MODEL 3889| LEAD: MODEL 3889| EXPLANTED: