BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2181059 · Received July 7, 2011

    Report

    Report Number
    1644487-2011-01516
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    November 11, 2010
    Report Date
    June 14, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT'S VNS WAS DISABLED FOR THE PATIENT'S COMFORT DUE TO EXCESSIVE COUGHING WITH VNS STIMULATION. VNS DIAGNOSTICS ARE UNABLE TO BE PERFORMED DUE TO THE PATIENT BEING UNABLE TO TOLERATE STIMULATION. THE COUGHING HAS BEEN OCCURRING WITH STIMULATION SINCE THE VNS GENERATOR WAS IMPLANTED ON (B)(6) 2010; THIS IS THE PATIENT'S SECOND VNS GENERATOR AND NO ISSUES WITH COUGHING WERE NOTED WITH THE PREVIOUS GENERATOR. THE REPORTER FEELS THERE IS A MALFUNCTION WITH THE VNS AND HAS REFERRED THE PATIENT FOR A SURGICAL CONSULT. VNS REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 2538

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male