BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2100638 · Received May 12, 2011

    Report

    Report Number
    1644487-2011-01041
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    ON (B)(6) 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED BY CASE MANAGEMENT. REVIEW OF CLINIC NOTES DATED (B)(6), 2011 REVEALED THAT THE PT PRESENTED WITH HIGH LEAD IMPEDANCE DURING A SYSTEM DIAGNOSTIC TEST RAN THAT DAY AND THE PT'S GENERATOR PULSE WAS DISABLED. THE TEST ALSO SHOWED THAT THE PT'S GENERATOR WAS AT ERI = YES. THE PT IS BEING REFERRED FOR SURGERY; HOWEVER, SURGERY HAS NOT BEEN SCHEDULED YET. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC. 302-30 6980

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR