BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 2052576 · Received April 8, 2011

    Report

    Report Number
    1644487-2011-00718
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    September 11, 2007
    Report Date
    March 10, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PATIENT HAD VOCAL CORD PARALYSIS. CURRENT DIAGNOSTICS WERE WITHIN NORMAL LIMITS. IT WAS ALSO INDICATED THAT THE PATIENT HAD THE PARALYSIS SINCE BEING IMPLANTED, AND IT OCCURS WHEN THE DEVICE STIMULATES. THE PATIENT HAS SEEN TWO DIFFERENT ENTS ABOUT THE ISSUE, WHO DIAGNOSED IT AS LEFT VOCAL CORD PARALYSIS. THEY ALSO SUGGESTED THAT THE VNS LIKELY CONTRIBUTES TO THE EVENT. THE PHYSICIAN SAID HE HAD NEVER TRIED TURNING THE DEVICE OFF. THE PATIENT DID NOT WANT TO DISABLE IT AS IT HAS MADE A DRAMATIC DIFFERENCE IN HIS LIFE. THE PATIENT MAY FOLLOW-UP WITH HIS IMPLANTING SURGEON ABOUT THIS ISSUE, HOWEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 1269

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other