BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1071726 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03879
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P97004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S LEAD IS BROKEN AND HAS QUIT WORKING AT THE SECOND AND THIRD ELECTRODE. SHE WAS EXPERIENCING LACK OF EFFECT AND NO STIMULATION SENSATION FROM HER INTERSTIM DEVICE. FURTHER INFO IS BEING REQUESTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MEDTRONIC PUERTO RICO OPERATIONS CO. IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEAD: MODEL UNKNOWN| EXPLANTED:| PROGRAMMER: MODEL 3037| IMPLANTED :