BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 5252838 · Received November 27, 2015

    Report

    Report Number
    1644487-2015-06581
    Event Type
    Injury
    Date Received
    November 27, 2015
    Date of Event
    January 1, 2015
    Report Date
    November 7, 2015
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AN ADVERSE EVENT PAPER TITLED "TEACHING NEUROIMAGES: OBSTRUCTIVE SLEEP APNEA TRIGGERED BY VAGUS NERVE STIMULATION" WAS PUBLISHED WHICH REPORTS OF A VNS PATIENT SUFFERING OBSTRUCTIVE SLEEP APNEA REPORTED AS WORSENED WITH VNS THERAPY. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783006 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR