BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2081514 · Received April 19, 2011

    Report

    Report Number
    1644487-2011-00844
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS - X-RAYS REVIEWED BY THE MANUFACTURER, LEAD PIN NOT FULLY INSERTED PAST THE CONNECTOR BLOCK OF GENERATOR.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD HIGH LEAD IMPEDANCE AT AN OFFICE VISIT. THE PATIENT WAS RECENTLY IMPLANTED WITH THE VNS THERAPY SYSTEM ON (B)(6) 2011. X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER WHICH NOTED THE LEAD PIN DID NOT APPEAR TO BE FULLY INSERTED INTO THE GENERATOR HEADER. THE PATIENT HAD LEAD PIN REINSERTION SURGERY PERFORMED ON (B)(6) 2011 WHICH RESOLVED THE HIGH LEAD IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2877

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR