BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 4965515 · Received August 4, 2015

    Report

    Report Number
    1644487-2015-05448
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 15, 2015
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT A PATIENT WAS EXPERIENCING VOCAL CORD PARALYSIS. THE VOCAL CORD PARALYSIS BEGAN APPROXIMATELY (B)(6) 2015. THE SUSPECTED CAUSE IS DUE TO THE PRESENCE OF THE DEVICE AND STIMULATION. THE PATIENT HAD A CONSULTATION FOR VNS REMOVAL. VNS REMOVAL SURGERY HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509134 LEAD MODEL 302 LEAD MUZ CYBERONICS - HOUSTON 302-20 200744

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention