BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR MODEL UNKNOWN

    MDR report key: 19848741 · Received July 28, 2024

    Report

    Report Number
    1644487-2024-00959
    Event Type
    Malfunction
    Date Received
    July 28, 2024
    Date of Event
    June 21, 2008
    Report Date
    August 15, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDED RELATED REPORT NUMBERS, INITIAL REPORT: INADVERTENTLY ONLY LISTED RELATED REPORT IN B5 SECTION.

    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

    REVIEW OF A SCIENTIFIC ARTICLE ABOUT PATIENTS' UNDERGOING VAGUS NERVE STIMULATION IN TREATMENT-RESISTANT DEPRESSION REPORTED ADVERSE EVENTS RELATED TO VNS THERAPY. STIMULATION-RELATED ADVERSE EVENTS, INCLUDING HOARSENESS, NECK PAIN, COUGH, NAUSEA, VOMITING, AND MYOCLONUS IN THE LEFT ARM, WERE MILD TO MODERATE IN SEVERITY AND A TRANSIENT COURSE. SUCH AES WERE CONTROLLED AND DISAPPEARED IN ALL PATIENTS BY ADJUSTING THE STIMULATION PARAMETERS, MAINLY THE DUTY CYCLE (ON-OFF PERIOD), THE FREQUENCY OF THE SIGNAL, AND THE PULSE WIDTH. ONE OF THE PATIENTS IN THE STUDY HAD A DEVICE THAT WAS DAMAGED BY A WORK ACCIDENT. THEY HAD STABLE REMISSION OF DEPRESSIVE SYMPTOMS FOR A COUPLE OF YEARS AFTER DEVICE FAILURE, SO THEY CHOSE TO CONTINUE STANDARD CARE AND NOT TO REPLACE THE BROKEN VNS DEVICE. MFR. REPORT# 1644487-2024-00959 WILL CAPTURE THE DEVICE DAMAGED IN A WORK ACCIDENT. MFR. REPORT# 1644487-2024-00960 WILL CAPTURE THE STIMULATION-RELATED ADVERSE EVENTS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037729 PULSE GENERATOR MODEL UNKNOWN GENERATOR MUZ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown