BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 17038734 · Received June 1, 2023

    Report

    Report Number
    1644487-2023-00692
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    July 15, 2020
    Report Date
    June 1, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿MIGRATION¿ IS NOT AVAILABLE. (NOTE THAT ALTHOUGH MIGRATION IS AN AVAILABLE MEDICAL DEVICE PROBLEM CODE, IN THIS REPORT¿S CONTEXT, THE MIGRATION DOES NOT REFLECT A PROBLEM WITH THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE. THEREFORE, A DEVICE PROBLEM CODE DOES NOT ADEQUATELY CAPTURE THE PATIENT¿S ADVERSE EVENT. 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. HEALTH EFFECT - CLINICAL CODE :E2326. HEALTH EFFECT - CLINICAL CODE :E171601.

    Description of Event or Problem · 0

    PATIENT WAS EXPERIENCING PAIN, COUGHING, BUMPS ON THE NECK, AND GENERATOR MIGRATION. PATIENT THEN HAD THEIR DEVICE EXPLANTED AS A RESULT OF THE MIGRATION. PATIENT STATES THAT THE DEVICE CAME OUT OF THE POCKET AND MIGRATED DOWN BEHIND HER LEFT BREAST WHICH CAUSED THE SETSCREW TO PULL AGAINST HER NERVE WHICH CAUSED ALL OF THE ADVERSE EVENTS. PATIENT ALSO NOTED THAT THEY HAD TO GO BACK LATER ON TO GET THE ANCHOR SUTURE REMOVED AS THE SURGEON DIDN'T REMOVE IT INITIALLY. DEVICE HAS NOT BEEN RETURNED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030238 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 204588 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other