BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3171069 · Received June 14, 2013

    Report

    Report Number
    1644487-2013-01793
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 17, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES AROUND THIS TIME LAST YEAR AND THAT INCREASING THE PATIENT'S SETTINGS HELPED TO DECREASE THE PATIENT'S SEIZURE FREQUENCY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270822 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 201004

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention