BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 17266493 · Received July 6, 2023

    Report

    Report Number
    1644487-2023-00862
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 13, 2023
    Report Date
    June 14, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 BY THE PATIENT THAT THEY ARE CONCERNED WITH THE SIDE EFFECTS OF INCREASE IN SEIZURES (WITH MULTIPLE HOSPITALIZATION DUE TO THE SEIZURES). THE PATIENT IS ALSO EXPERIENCING AURAS ASSOCIATED WITH THE URGE TO GO TO THE BATHROOM. THIS WILL BE CONSIDERED A CHANGE IN SEIZURE PATTERN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PATIENT REPORTS IRREGULAR HEART BEAT, THE DEVICE WAS TURNED DOWN AS A RESULT. THE PATIENT STATES THAT SOMETIMES HIS HEART BEATS REALLY FAST, AND OTHER TIMES IT BEATS REALLY SLOW. PATIENT WAS CONSIDERING REMOVAL. THE PATIENT DOES REPORT A HISTORY OF INCREASED HEAR RATE PRIOR TO SEIZURE. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973266 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 205123

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention