BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 2831425 · Received November 14, 2012

    Report

    Report Number
    1644487-2012-02997
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    July 17, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE VNA PATIENT HAS BEEN HAVING PAIN AND WAS SEEN BY THE ENT WHO DIAGNOSED HER WITH LEFT VOCAL CORD PARESIS. THE NEUROLOGIST REQUESTED THAT THE LEAD BE CHECKED TO SEE IF IT WAS DAMAGED. IT WAS LATER NOTED THAT THE PATIENT'S DIAGNOSTICS WERE WITHIN RANGE. THE PARESIS AND PAIN WERE FIRST OBSERVED THE DAY AFTER SURGERY AND WERE BELIEVED TO BE DUE TO THE IMPLANT SURGERY THAT OCCURRED ON (B)(6) 2012. THE PAIN AND PARESIS OCCUR ALL THE TIME. THE ONLY INTERVENTION PLANNED WAS VOICE THERAPY. NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE EVENTS. THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF LEFT VOCAL CORD PARESIS PRIOR TO VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 303 LEAD LYJ CYBERONICS INC 303-20 202089

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other