BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY GEN MODEL 8103

    MDR report key: 21337519 · Received February 7, 2025

    Report

    Report Number
    1644487-2025-00115
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    August 26, 2024
    Report Date
    April 18, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    MUZ
    UDI-DI
    05425025750504
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 HAVE NOT 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. F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM "TISSUE DAMAGE" IS NOT AVAILABLE. H3. DEVICE EVALUATED BY MANUFACTURER, CODE 81, DEVICE EVALUATION IS NOT NECESSARY AS REPORTED EVENT(S) ARE NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿EDEMA¿ IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCE A HEMATOMA AT IMPLANT SITE. THE EVENT IS SERIOUS, LIFE THREATENING, SEVERE, AND REQUIRED HOSPITALIZATION. SURGICAL INTERVENTION OF FIXING THE LEAKING ARTERY WAS TAKEN TO PREVENT A LIFE THREATENING INJURY. THE EVENT IS POSSIBLY RELATED TO PROCEDURE AND RECOVERED/RESOLVED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE ADVERSE EVENT THE PATIENT WAS EXPERIENCING WAS NECK SWELLING WITH INTERVENTION OF NECK EXPLORATION AND HEMATOMA EVACUATION. THE PHYSICIAN CONFIRMED THE PRESENTING SYMPTOM WAS NECK SWELLING BUT THE UNDERLYING CAUSE WAS THE HEMATOMA. NO FURTHER SURGICAL INTERVENTION HAS BEEN REPORTED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN REVIEWED THE MEDICAL RECORDS FOR THE PATIENT, INCLUDING THE NOTE DOCUMENTING THE PROCEDURE FOR NECK EXPLORATION AND HEMATOMA EVACUATION RELATED TO THE NECK SWELLING. THE PHYSICIAN STATED THERE WAS NO MENTION OF A LEAK OR DOCUMENTATION SUPPORTING AN ARTERY BEING NICKED IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125151 SYMMETRY GEN MODEL 8103 GENERATOR MUZ CYBERONICS - HOUSTON 8103 206229 05425025750504

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Life Threatening| R| H