BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 3963492 · Received July 29, 2014

    Report

    Report Number
    1644487-2014-01882
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAD VOCAL CORD PARALYSIS. IT IS UNKNOWN WHEN THE PATIENT BEGAN EXPERIENCING VOCAL CORD PARALYSIS, BUT IT WAS NOTED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY A FEW MONTHS AGO. DURING THE PROCEDURE, THE PATIENT¿S ENTIRE LEAD WAS EXPLANTED (INCLUDING THE ELECTRODES). ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442176 LEAD MODEL UNKNOWN LEAD LYJ CYBERONICS INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other