BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 885326 · Received July 26, 2007

    Report

    Report Number
    1644487-2007-01045
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    January 1, 2006
    Report Date
    June 27, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A POSSIBLE LEAD DISCONTINUITY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A PT HAD HIGH IMPEDANCE READINGS AT AN OFFICE VISIT, INDICATING A POSSIBLE LEAD BREAK. THE PT WAS ALSO EXPERIENCING AN INCREASE IN SEIZURES. THE SEIZURE INCREASE WAS NOT GREATER THAN PRE-VNS BASELINE LEVELS. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A SUSPICIOUS AREA AT THE NEGATIVE ELECTRODE THAT APPEARS TO BE A BREAK. REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 2802

    Patients

    Seq Age Sex Outcome Treatment
    1 YR