BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1963654 · Received December 21, 2010

    Report

    Report Number
    1644487-2010-02798
    Event Type
    Malfunction
    Date Received
    December 21, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEAD IMPEDANCE HAD RESULTED FROM A DIAGNOSTIC TEST WHEN THE VNS PT WAS SEEN FOR A F/U VISIT WITH THE NEUROLOGIST. IN ADDITION, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS SET TO YES. THERE WAS NO REPORT OF CAUSAL OR CONTRIBUTORY TRAUMA OR MANIPULATION OF THE DEVICE PRIOR TO WHEN HIGH IMPEDANCE WAS OBSERVED. NO X-RAYS WERE TAKEN TO ASSESS THE CONTINUITY OF THE DEVICE. THE PT SUBSEQUENTLY HAD SURGERY WHERE THE LEAD AND GENERATOR WERE REPLACED. THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO MFR WHERE ANALYSIS IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 38176C

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR