BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2172655 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01622
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    November 5, 2008
    Report Date
    June 25, 2018
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT A VNS PT'S DEVICE WAS TURNED OFF SINCE PT COULD NOT TOLERATE THE SIDE EFFECTS. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 10489

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female Required Intervention