BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1101832 · Received August 6, 2008

    Report

    Report Number
    1644487-2008-01776
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    January 1, 2006
    Report Date
    July 7, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY THE VNS PT THAT SHE HAS BEEN EXPERIENCING AN INCREASE IN SEIZURE ACTIVITY AND HYPOTENSION SINCE HER REIMPLANTATION OF GENERATOR IN 2006. SHE WAS PUT ON A RESPIRATOR AT THE ER TO HELP WITH THE REPORTED EVENTS. GOOD FAITH ATTEMPTS MADE WITH THE TREATING PHYSICIAN TO OBTAIN ADD'L INFO REGARDING THE REPORTED EVENTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 13894

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention