BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2241416 · Received August 18, 2011

    Report

    Report Number
    1644487-2011-01878
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S PHYSICIAN THAT DURING THE PATIENT'S BATTERY REPLACEMENT, A HIGH LEAD IMPEDANCE WAS DISCOVERED. THE LAST "NEUROLOGY NOTE" STATED THAT THE SYSTEM DIAGNOSTIC TEST WAS "FINE." THE PATIENT THEN UNDERWENT A FULL REVISION. THERE HAD BEEN NO REPORTED TRAUMA OR MANIPULATION TO THE PATIENT. THE EXPLANTED PRODUCT WAS RETURNED FOR EVALUATION BY THE MANUFACTURER. DRIED BODY FLUIDS WERE OBSERVED IN THE INNER SILICONE TUBING OF THE RETURNED LEAD PORTION, THOUGH NO POINTS OF ENTRY OTHER THAN THE CUT LEAD ENDS WERE IDENTIFIED. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED WITHIN THE RETURNED LEAD PORTIONS. NO PERFORMANCE ISSUE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 5549

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR