BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1062996 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01393
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT COMMUNICATION WITH THE PATIENT'S GENERATOR COULD NOT BE ESTABLISHED. GENERATOR END OF SERVICE IS SUSPECTED, HOWEVER, THERE IS AN ALLEGATION THAT THE GENERATOR REACHED END OF SERVICE PREMATURELY. PATIENT WILL HAVE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 011818

    Patients

    Seq Age Sex Outcome Treatment
    1