BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1120759 · Received August 15, 2008

    Report

    Report Number
    9614453-2008-05009
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD IMPEDANCE MEASUREMENTS WERE NOT CONSISTENT. ON THE FIRST READINGS ALL PAIRS WERE GREATER THAN 4,000 OHMS. THE SECOND TIME ELECTRODES 0-2 HAD HIGH IMPEDANCE BUT 3 WAS FINE. THESE READINGS WERE NOT REPRODUCIBLE. THE PHYSICIAN DISCONNECTED THE LEAD FROM THE IPG AND THEN CONNECTED THE LEAD TO AN EXTERNAL STIMULATOR. THE PT SHOWED NO MOTOR OR SENSITIVE REACTIONS. THE LEAD WAS THEN REPLACED AND CONNECTED TO THE ORIGINAL IPG. NO SURGICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC SWISS MANUFACTURING FACILITY 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3889| EXPLANTED