BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 304-20

    MDR report key: 2870687 · Received December 12, 2012

    Report

    Report Number
    1644487-2012-03313
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 16, 2012
    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

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT WAS SCHEDULED FOR AN OTOLOARYNGOLOGY CONSULTATION AT THE (B)(6) 2012, BUT IT IS NOT KNOWN IF THIS HAS OCCURRED TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT DEVELOPED LEFT VOCAL CORD PARALYSIS FOLLOWING VNS LEAD AND GENERATOR REPLACEMENT SURGERY, WHICH OCCURRED ON (B)(6) 2012. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED HE DOES NOT USUALLY DO DIAGNOSTICS TESTING WHEN THE VNS SETTINGS ARE BELOW 1MA OUTPUT CURRENT. THE REPORTER HAS NOT RECEIVED ANY ADDITIONAL INFORMATION FROM THE ENT PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 304-20 LEAD LYJ CYBERONICS INC 304-20 202126

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other