BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1200062 · Received October 15, 2008

    Report

    Report Number
    3004209178-2008-06565
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELT NO STIMULATION SENSATION. SHE HAD A PROCEDURE DONE AND AFTER, WHEN SHE TRIED TO TURN THE DEVICE BACK ON, IT DIDN'T WORK. 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 81 YR IMPLANTED:| PROGRAMMER: MODEL 3031A| EXPLANTED:| LEAD: MODEL 3093| EXPLANTED:| EXTENSION: MODEL 3095| IMPLANTED: