BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 15130211 · Received July 29, 2022

    Report

    Report Number
    1644487-2022-00914
    Event Type
    Injury
    Date Received
    July 29, 2022
    Date of Event
    April 9, 2021
    Report Date
    November 28, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED TRANSIENT VOCAL CORD PARALYSIS RELATED TO VNS. IT WAS ALSO NOTED THAT THE PATIENT'S OVERALL SEIZURE CONTROL HAS DECREASED AND SHE IS NOW HAVING SEIZURES WEEKLY AND IS FALLING MORE. THE PATIENT'S VNS SETTINGS WERE INCREASED AS WELL AS MEDICATIONS. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE EXPLANTED GENERATOR WAS RECEIVED BUT PRODUCT ANALYSIS IS STILL UNDERWAY.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS A NEOS=YES CONDITION) WAS PERFORMED. THE PULSE GENERATOR WAS OPENED, THE MEASURED BATTERY VOLTAGE CONFIRMED A NEOS (NEAR END OF SERVICE) CONDITION. THERE WERE NO ADDITIONAL PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN'S OFFICE NOTING THAT THE INCREASED SEIZURES IS DUE TO LOW BATTERY AND ARE BACK TO PRE-VNS BASELINE LEVELS. THE PATIENT UNDERWENT A BATTERY REPLACEMENT AND THEIR BATTERY STATUS WAS NOTED TO BE AT NEAR END OF SERVICE AT THE TIME OF EXPLANT. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426252 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 202799

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Required Intervention| S