BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 18067946 · Received November 3, 2023

    Report

    Report Number
    1644487-2023-01593
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Date of Event
    October 11, 2023
    Report Date
    November 3, 2023
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    FDA MEDWATCH REPORT MW5146914 WAS RECEIVED INDICATING THAT; CYBERONICS DEVICE WERE RETURNED TO MEDTRONIC FOR UNKNOWN REASONS;. THE GENERATOR IS AN M104 SN: UNKNOWN. THE REASON FOR RETURN WAS NOT NOTED AND THE EVENT IS LISTED AS MALFUNCTION. THE DEVICE SERIAL NUMBER, PATIENT, PHYSICIAN, AND REPORTER ARE UNKNOWN. NO OTHER INFORMATION IS AVAILABLE. THEREFORE, NO FURTHER INVESTIGATION CAN BE COMPLETED AT THIS TIME. THE DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960410 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS - HOUSTON 104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown