BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 20334249 · Received September 30, 2024

    Report

    Report Number
    1644487-2024-01213
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    September 5, 2024
    Report Date
    December 31, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE PATIENT DID NOT EXPERIENCE A CARDIAC EVENT DUE TO VNS SURGERY. THE PHYSICIAN ALSO NOTED THE SAME MACHINE WAS USED FOR BOTH ECGS THE PATIENT UNDERWENT. THE PATIENTS SETTINGS AND DIAGNOSTICS WERE ALSO PROVIDED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND NEGATIVE T WAVES WERE SEEN ON INFEROLATERAL ECG LEADS. THE PATIENT'S CARDIOLOGIST NOTED THE CAUSE OF THESE WERE RELATED TO THE VNS, HOWEVER THE T WAVES WERE NOT PRESENT ON THE ECG THE PATIENT HAD THREE MONTHS AGO. THE PHYSICIAN NOTED THERE MAY BE CHANGED IN THE PATIENT'S ATRIOVENTRICULAR CONDUCTION, BUT NO CHANGES IN REPOLARIZATION WERE SEEN. IT WAS DETERMINED THAT THE HOSPITALIZATION WAS NOT CAUSED BY VNS. THE IMPEDANCE IS NOTED TO BE WITHIN NORMAL LIMITS. THE PATIENT WAS NOTED TO HAVE 1ST DEGREE ATRIOVENTRICULAR BLOCK AND RIGHT BRANCH BLOCK (2019) BEFORE VNS IMPLANTATION. EKG MODIFICATION ((B)(6) 2024) APPEARS AFTER GENERATOR CHANGE CONSISTING IN NEGATIVE T WAVES IN D2 D3 AVF V4 V V6, NOT VISIBLE ON PREVIOUS EKGS ((B)(6) 2024). THE CONSULTED CARDIOLOGIST CONCLUDED IN A MODIFICATION IN CONNECTION WITH VNS. THERE WAS NOT "CARDIAC" CLINICAL MANIFESTATIONS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582672 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 7637 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H