BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1083606 · Received July 29, 2008

    Report

    Report Number
    3004209178-2008-04482
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Report Date
    January 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION AT THE IPG LOCATION AFTER EXPOSURES TO STORE'S SECURITY GATE. THE DEVICE WAS ON DURING THE EXPOSURE. THE PT IS AT HOME AND IN GOOD CONDITION. 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 Required Intervention EXTENSION MODEL 3095 LOT#NAH001704V| LEAD MODEL 3886 LOT#J0206519V| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 3031A LOT#NGM002729P