BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1081939 · Received July 23, 2008

    Report

    Report Number
    1644487-2008-01679
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    April 27, 2005
    Report Date
    June 8, 2006
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS HAD THE LEAD AND GENERATOR EXPLANTED AS THE PT REPORTED THAT THEY WERE NO LONGER HAVING DEPRESSION. THE EXPLANTED DEVICES WERE RETURNED TO MFR FOR ANALYSIS. ANALYSIS OF THE LEAD REVEALED THAT A DISCONTINUITY LOCATED AT APPROXIMATELY 13CM FROM THE END OF BIFURCATION SHOWED THAT PITTING OR ELECTRO-PLATING CONDITIONS HAVE OCCURRED. THE COIL BREAK SURFACES SHOWED MECHANICAL DISTORTION ON THE COIL WIRES MOST LIKELY CAUSED BY A CONTACTING SURFACE, RESULTING IN THE COIL DISCONTINUITY. FURTHERMORE, ANALYSIS OF DIAGNOSTIC HISTORY AVAILABLE IN-HOUSE REVEALED THAT HIGH LEAD IMPEDANCE WAS PRESENT WITH END OF SERVICE STATUS SET TO NO, APPROXIMATELY ONE YEAR PRIOR TO EXPLANTATION OF THE DEVICE. STIMULATION HAD BEEN DISABLED THREE MONTHS AFTER THE HIGH LEAD IMPEDANCE TEST RESULT WAS INITIALLY OBSERVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN ARE UNDERWAY. THE PATIENT WAS RE-IMPLANTED WITH A NEW VNS SYSTEM AT A LATER DATE. ANALYSIS OF THE EXPLANTED GENERATOR REVEALED NORMAL FUNCTION AND NO ANOMALIES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 MUZ CYBERONICS, INC. 300-20 976

    Patients

    Seq Age Sex Outcome Treatment
    1