BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD MODEL 300

    MDR report key: 1930347 · Received November 24, 2010

    Report

    Report Number
    1644487-2010-02676
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MFR REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE NURSE THAT THE PT WAS IN HER OFFICE AS HE COULD NOT FEEL THE MAGNET STIMULATION. NURSE PERFORMED SYSTEM DIAGNOSTICS AND SHE GOT A HIGH IMPEDANCE WARNING. NORMAL MODE DIAGNOSTICS SHOWED EVERYTHING WORKING WITHIN NORMAL LIMITS. X-RAYS WERE TAKEN AND SENT TO MFR FOR REVIEW. THERE WAS A CLEAR LEAD DISCONTINUITY OBSERVED IN ONE OF THE COIL FOLLOWING THE ANCHOR TETHER AFTER THE FIRST TIE-DOWN. FOLLOW UP WITH THE NURSE REVEALED THAT THE PT IS NOT HAVING AN INCREASE IN SEIZURES WHICH IS UNUSUAL FOR HIM. PT'S LAST ACCEPTABLE DIAGNOSTICS WERE OBTAINED ON (B)(6) 2009. NO PT MANIPULATION OR TRAUMA WAS REPORTED. PT'S INCREASE IN SEIZURES WAS NOT ABOVE PRE-VNS BASELINE AS PER THE NURSE. PT UNDERWENT A FULL REVISION SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN EXPLANTED PRODUCTS FOR ANALYSIS HAS BEEN UNSUCCESSFUL TILL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD MODEL 300 LYJ CYBERONICS, INC. 300-30

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention