BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1081550 · Received July 25, 2008

    Report

    Report Number
    1644487-2008-01702
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED FROM THE HOSPITAL STATING THAT THE GENERATOR WAS REPLACED DUE TO BATTERY DEPLETION AND MALFUNCTION NOTED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS. PRODUCT ANALYSIS IS PENDING ON THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102R 012830

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR