BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3100415 · Received May 8, 2013

    Report

    Report Number
    1644487-2013-01300
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 19, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED BY THE PATIENT'S MOTHER THAT THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES. THE LAST TIME THE PATIENT WAS INTERROGATED WAS IN 2005. THE PATIENT IS INCARCERATED, AND ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200585 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR