BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 19342619 · Received May 17, 2024

    Report

    Report Number
    1644487-2024-00571
    Event Type
    Death
    Date Received
    May 17, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 14, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750054
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 THAT THE PATIENT RECENTLY PASSED AWAY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    AN OBITUARY REVIEW REVEALED THAT THE PATIENT PASSED AWAY PEACEFULLY IN HER HOME AND THE PATIENT HAD BEEN BEDRIDDEN HER WHOLE LIFE. ADDITIONAL INFORMATION RECEIVED NOTING THAT THE CAUSE OF DEATH WAS HYPOXIC ASPHYXIATION DUE TO CHRONIC ASTHMA AND NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530001 PULSE GEN MODEL 105 GENERATOR LYJ LIVANOVA USA, INC. 105 203996 05425025750054

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Death