BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 20096814 · Received August 29, 2024

    Report

    Report Number
    1644487-2024-01100
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 4, 2024
    Report Date
    August 29, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. ADDITIONAL RELATED MANUFACTURER REPORT # - 1644487-2024-01098.

    Description of Event or Problem · 0

    DURING A REVIEW OF SCIENTIFIC ARTICLES REGARDING VNS THERAPY, AN ARTICLE TITLED "COMPLICATIONS AND MORTALITY RATE OF VAGUS NERVE STIMULATION FOR DRUG-RESISTANT EPILEPSY" WAS LOCATED AND FOUND TO HAVE MULTIPLE COMPLAINTS FOR MULTIPLE PATIENTS.. THE BREAKDOWN OF THE REPORTED ADVERSE EVENTS ARE AS FOLLOWS: INFECTION (4 PATIENTS, ALL RECEIVED ANTIBIOTICS AND HAD DEVICE REMOVED DUE TO INFECTION), LEAD BREAKAGE (8 PATIENTS, ALL HAD LEADS REPLACED), DEVICE EXTRUSION OR MIGRATION (2 PATIENTS, BOTH OF WHOM HAD DEVICE REMOVED)), DEVICE DISABLEMENT (3 PATIENTS, DISABLED DUE TO UNSPECIFIED COMPLICATIONS AND/OR LACK OF EFFICACY), VOCAL CORD PARALYSIS (4 PATIENTS), MYOCARDIAL INFARCTION (1 PATIENT WHO EVENTUALLY HAD A PACEMAKER ALSO IMPLANTED), OBSTRUCTIVE SLEEP APNEA (3 PATIENTS, 1 OF WHOM HAD A UVUOLAPALATOPHARYNGOPLASTY) . IT WAS ALSO REPORTED IN THE PAPER THAT 4 PATIENTS TOTAL PASSED AWAY OVER THE 23 YEARS (1DUE TO SEIZURES, 2 PROBABLE SUDEP, 1 MEDICAL COMPLICATIONS). MFR. REPORT #1644487-2024-01098 CAPTURES THE REPORTED INFECTION, VOCAL CORD PARALYSIS, MYOCARDIAL INFARCTION, UNSPECIFIED ADVERSE EVENT, SLEEP APNEA, AND DEVICE EXTRUSION. MFR. REPORT #1644487-2024-01100 (THIS REPORT) CAPTURES THE REPORTED LEAD FRACTURE. MFR. REPORT# 1644487-2024-01101 CAPTURES THE REPORTED PATIENT DEATHS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911599 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS - HOUSTON

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown