BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 14193885 · Received April 25, 2022

    Report

    Report Number
    1644487-2022-00481
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    May 26, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 LIVANOVAS 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 NOTED THAT THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT AND THEY WANTED TO MOVE THE SURGERY SOONER AS SHE WAS HAVING INCREASED SEIZURES. THE GENERATOR WAS REPLACED. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED TO DATE. INFORMATION WAS RECEIVED FROM THE PHYSICIAN NOTING THE PATIENT HAS NOT BEEN SEEN SINCE DECEMBER AND THE CAREGIVER NOTED THE PATIENT IS NOT HAVING ANY SEIZURES. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS NOTED THAT THE EXPLANTED GENERATOR WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184278 PULSE GEN MODEL 104 GENERATOR LYJ LIVANOVA USA, INC. 104 3213

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention