BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 4173567 · Received October 15, 2014

    Report

    Report Number
    1644487-2014-02693
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED SEIZURES. IT IS UNCLEAR WHETHER OR NOT THE SEIZURES ARE AN INCREASE ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. IT WAS REPORTED THAT THE DEVICE WAS NOT NEARING END OF SERVICE AND THE PATIENT WAS REFERRED FOR PROPHYLACTIC GENERATOR REPLACEMENT. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654676 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 013476

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention