BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL UNKNOWN

    MDR report key: 1963861 · Received December 22, 2010

    Report

    Report Number
    1644487-2010-02874
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US BY OUR COUNTRY REPRESENTATIVE IN (B)(4) THAT DURING A REVISION OF A 101 GENERATOR (IMPLANTED IN 2002) BEING REPLACED DUE TO END OF BATTERY LIFE HIGH IMPEDANCE WAS NOTED WITH THEIR NEW GENERATOR AS THEIR 101 WAS AT END OF BATTERY LIFE. WHEN THE PATIENT'S HAD THEIR 102R GENERATOR IMPLANTED AND DIAGNOSTIC TESTING PERFORMED THE HIGH IMPEDANCE WAS FIRST DETECTED. SYSTEM DIAGNOSTIC TESTING WAS PERFORMED FOUR TIMES, REINSERTION OF THE LEAD IN THE GENERATOR AT SEVERAL TIMES, BUT HIGH IMPEDANCE WAS STILL PRESENT. THE SURGEON IMPLANTED THE 102R BUT DID NOT PROGRAM THE GENERATOR ON. THE PATIENT HAD BEEN INTO CLINIC SEVERAL TIMES PRIOR TO SURGERY BUT ONLY AN INTERROGATION WAS PERFORMED AND NO DIAGNOSTIC TESTING. AT THIS TIME NO NEW DATE HAD BEEN SCHEDULED FOR THEIR FULL REVISION. IT IS UNKNOWN IF THE PATIENT HAD ANY FALL OR INJURY PRECEDING THEIR HIGH LEAD IMPEDANCE BEING ATTAINED THAT MAY HAVE ATTRIBUTED TO IT. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS SURROUNDING THEIR HIGH LEAD IMPEDANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR