BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1990002 · Received February 3, 2011

    Report

    Report Number
    1644487-2011-00168
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PT HAD HIGH LEAD IMPEDANCE DURING SYSTEM DIAGNOSTICS IMMEDIATELY FOLLOWING GENERATOR REVISION SURGERY. NO TRAUMA OR PT MANIPULATION HAD OCCURRED AND THE NEUROLOGIST PROGRAMMED THE GENERATOR OFF. THE REVIEW OF NEUROSURGEON'S HANDHELD REVEALED THAT PT HAD HIGH LEAD IMPEDANCE AT THE TIME OF SURGERY. PT'S X-RAYS WERE REVIEWED BY MANUFACTURER: THE ALIGNMENT OF THE POSITIVE AND NEGATIVE ELECTRODES APPEARED TO BE NORMAL. A GROSS LEAD FRACTURE WAS VISUALIZED RIGHT AFTER STRAIN RELIEF BEND. THE FILTER FEED-THRU WIRES APPEARED TO BE INTACT. THE GENERATOR WAS PLACED IN THE LEFT CHEST IN A NORMAL ORIENTATION. THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED. REVISION SURGERY TO ADDRESS THE LEAD FRACTURE IS LIKELY BUT HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 010599

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR