BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3889328 · Received June 23, 2014

    Report

    Report Number
    1644487-2014-01566
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    February 18, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE HAS EXPERIENCED AN INCREASE IN SEIZURES RECENTLY WHICH HE ATTRIBUTES TO THE STRESS OF SOCIAL SECURITY DISABILITY REVIEW. THE PATIENT ALSO REPORTED THAT HE PASSED OUT. THE PATIENT REPORTED THAT THE NEUROLOGIST INCREASED DEVICE OFF TIME FROM 5 MINUTES TO 3 MINUTES AND INCREASED HIS KEPPRA DOSAGE TO 1500 MG A DAY. THE PATIENT REPORTED THAT THE NEUROLOGIST CHECKED THE VNS AND FOUND THAT THERE WAS STILL BATTERY LIFE REMAINING. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366295 PULSE GEN MODEL 102 GENERATOR LYJ LIVANOVA USA, INC. 102 010182

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R