BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 2102364 · Received May 20, 2011

    Report

    Report Number
    1644487-2011-01154
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA POSTER PRESENTATION ENTITLED "VAGUS NERVE STIMULATOR IN A PEDIATRIC POPULATION-SURGICAL TECHNIQUE CONSIDERATIONS IN YOUNG CHILDREN" THAT ONE PT UNDERWENT REVISION SURGERY DUE TO DEHISCENCE WOUND AND POSSIBLE MECHANICAL PROBLEMS. NO FURTHER DETAILS GIVEN AND ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1