BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2880320 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03404
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD AN INCREASE IN SEIZURE, UNKNOWN IF ABOVE OR BELOW PRE-VNS BASELINE. THE RELATIONSHIP OF THE INCREASE TO VNS IS UNKNOWN. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 3324

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR