BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 6916399 · Received October 5, 2017

    Report

    Report Number
    1644487-2017-04547
    Event Type
    Death
    Date Received
    October 5, 2017
    Date of Event
    July 16, 2017
    Report Date
    November 1, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KAWAI, K. & TANAKA, T. (2017). OUTCOME OF VAGUS NERVE STIMULATION FOR DRUG-RESISTANCE EPILEPSY: THE FIRST THREE YEARS OF A PROSPECTIVE JAPANESE REGISTRY. EPILEPTIC DISCORD, 19(3), 1-12. DOI:10.1684/EPD.2017.0929.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR?: THE DEATHS ARE NOT SUSPECTED TO BE CAUSED BY VNS, SO NO ANALYSIS IS NECESSARY. DEVICE EVALUATED BY MFR?, CORRECTED DATA: INITIAL REPORT INADVERTENTLY INDICATED INCORRECT EVALUATION STATUS FOR DEATHS NOT SUSPECTED TO BE RELATED TO VNS.

    Description of Event or Problem · 1

    A RESEARCH ARTICLE COMPRISED OF DATA FROM A NATIONAL REGISTRY OF ALL VNS PATIENTS IMPLANTED BETWEEN JULY 2010 AND DECEMBER 2012 REPORTED SEVERAL DEATHS, ADVERSE EVENTS, AND DEVICE MALFUNCTIONS. THIS REPORT CAPTURES THE DEATHS REPORTED IN THE ARTICLE. THE INFECTIONS AND INTRAOPERATIVE AND POSTOPERATIVE CARDIAC COMPLICATIONS OBSERVED DURING THE STUDY ARE CAPTURED IN MFR REPORT #1644487-2017-04548, THE HIGH IMPEDANCE OBSERVED DURING THE STUDY IS CAPTURED IN MFR REPORT #1644487-2017-04549, AND THE SEIZURE INCREASES OBSERVED DURING THE STUDY ARE CAPTURED IN MFR. REPORT #1644487-2017-04550. FOURTEEN PATIENTS PASSED AWAY DURING THE STUDY: 6 WERE SUDDEN UNEXPLAINED DEATHS IN EPILEPTIC PATIENTS, 1 DIED DUE TO RECTAL CANCER, 1 DIED DUE TO PRIMARY BRAIN TUMOR, 1 DIED DUE TO LUNG CANCER, 1 DIED DUE TO PNEUMONIA, 1 DIED DUE TO A SUBARACHNOID HEMORRHAGE, 1 DIED AFTER DROWNING DURING BATHING, 1 DIED DUE TO SUFFOCATING AFTER A SEIZURE, AND 1 DIED DUE TO UNKNOWN CAUSES. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695992 PULSE GEN MODEL UNKNOWN GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death