BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3930296 · Received July 11, 2014

    Report

    Report Number
    1644487-2014-01765
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CURRENTLY AT THE HOSPITAL BECAUSE HE HAD A BAD SEIZURE. IT WAS REPORTED THAT THE PATIENT HAD BEEN WITHOUT A MAGNET FOR SOME TIME AND WAS PROVIDED A NEW ONE BY THE CLINIC. THE PATIENT WAS SCHEDULED FOR FOLLOW-UP WITH THE NEUROLOGIST. THE PATIENT'S DEVICE WAS CHECKED DURING FOLLOW-UP WITH THE NEUROLOGIST AND FOUND TO BE WORKING PROPERLY. THERE WAS NO INDICATION OF END OF SERVICE. MEDICATION ADJUSTMENTS WERE PERFORMED. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREATING NURSE PRACTITIONER SAID THAT THE VNS IS WORKING PROPERLY. THE COMPANY REPRESENTATIVE THEREFORE BELIEVES THAT THE NURSE PRACTITIONER LIKELY DOES NOT BELIEVE THE HOSPITALIZATION AND SEIZURE WERE RELATED TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406704 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2574

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention