BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 3190806 · Received June 26, 2013

    Report

    Report Number
    1644487-2013-01931
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 1, 2013
    Report Date
    November 15, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INDICATED THAT THE PATIENT WAS NOT HAVING AN INCREASE IN SEIZURES BUT THERE WAS SOME INFORMATION THAT WAS RECEIVED AT THAT TIME THAT THEY WERE HAVING AN INCREASE IN SEIZURES. ALTHOUGH ANOTHER SOURCE SAID THEY WERE NOT HAVING AN INCREASE IN SEIZURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.828 VOLTS AS MEASURED SHOWS A NON-IFI CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 86.644% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE PATIENT WAS HAVING UNCONTROLLED SEIZURES AND WAS EVALUATED IN A HOSPITAL. THE PATIENT TYPICALLY HAS 8-10 SEIZURES A MONTH WITH VNS BUT HAD 8 SEIZURES IN ONE DAY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS EXPERIENCING MORE SEVERE SEIZURES ALTHOUGH SHE WAS NOT HAVING AN INCREASE IN SEIZURES. THE PATIENT WAS LATER HOSPITALIZED DUE TO SEIZURES. THE PATIENT HAD A GENERATOR REPLACEMENT. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE PATIENT'S LEAD WAS IMPLANTED ON THE WRONG NERVE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290401 PULSE GEN MODEL 104 GENERATOR LYJ LIVANOVA USA, INC. 104 3220

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR