BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3063866 · Received April 17, 2013

    Report

    Report Number
    1644487-2013-01047
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    January 1, 2013
    Report Date
    December 10, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 INDICATED THE PATIENT HAD AN INCREASED NUMBER OF SEIZURES DURING (B)(6) 2013 WHERE HE HAD OVER NINE EPISODES LASTED ONE MINUTE THAT BEGAN AS COMPLEX PARTIAL SEIZURES. THE PATIENT WAS AVERAGING 1-4 SEIZURES PER MONTH LASTING ONE MINUTE. THE SEIZURES WERE CP SEIZURES ALONE OR FOLLOWED BY CONVULSIONS. FOLLOW-UP SHOWED THAT A RELATIONSHIP OF THE SEIZURES TO THE PATIENT'S PRE-VNS SEIZURE LEVEL COULD NOT BE PROVIDED BECAUSE THE PATIENT HAD NOT BEEN SEEN AT THAT OFFICE PRIOR TO VNS PLACEMENT. THE INCREASE IN SEIZURES WAS BELIEVED TO BE RELATED TO BATTERY DEPLETION. NO MEDICATION CHANGES OR EXTERNAL FACTORS PRECEDED THE INCREASE IN SEIZURES, BUT THE PATIENT'S MEDICATION WAS INCREASED DUE TO THE INCREASE IN SEIZURES: THE PATIENT HAD NOT HAD ANY SEIZURES SINCE THAT MEDICATION CHANGE. THE PATIENT'S SETTINGS AND BATTERY STATUS WAS PROVIDED. THE REPLACEMENT INDICATOR WAS SEEN. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    IT WAS FOUND THAT THE PATIENT UNDERWENT REPLACEMENT. THE EXPLANT FACILITY DOES NOT RETURN EXPLANTED DEVICES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165073 PULSE GEN MODEL 102 GENERATOR LYJ LIVANOVA USA, INC. 102 13620

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other