BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 1120748 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04963
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 16, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD INTERMITTENT STIMULATION AND NO THERAPEUTIC EFFECT. THE PT FELT THE STIMULATION FOR ONLY A SMALL PERCENT OF THE TIME. THE IMPEDANCE MEASUREMENTS READ 2500 OHMS ON ALL THE ELECTRODES. THE LEAD AND EXTENSION WERE REPLACED. THE IPG WAS NOT AT END OF LIFE BUT WAS ALSO REPLACED AT THE SAME TIME AS THE LEAD. 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 37 YR Required Intervention EXPLANTED| EXTENSION MODEL 3095| LEAD MODEL 3889| EXPLANTED| PROGRAMMER MODEL 3031A