BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1202903 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06675
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MPROC, JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE, AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT FELT A BURNING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR DOWN TO THE TINED LEAD IN MARCH. IN APRIL THE INS HAD BEEN SWITCHED OFF FOR A WEEK AND THE BURNING SENSATION STOPPED. WHEN THE INS WAS TURNED BACK ON THE BURNING SENSATION STARTED AGAIN. THE TINED LEAD WAS REMOVED. THE PHYSICIAN NOTICED THERE WAS A SORT OF DISCONTINUITY BETWEEN ELECTRODE 0 AND THE SILICON INSULATION. FURTHER INFO IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MPROC, JUNCOS IPG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL 3889 LOT# B0710730K| IMPLANTED