BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2190782 · Received July 26, 2011

    Report

    Report Number
    1644487-2011-01678
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 25, 2010
    Report Date
    July 7, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE VIA AN X-RAY REPORT THAT A VNS PT HAD AN ASYMMETRY OF VOCAL CORDS, WITH THE LEFT CORD IN A PARAMEDIAN POSITION, SUGGESTING A POSSIBILITY OF VOCAL CORD PARALYSIS. THE NURSE INDICATED THAT DIAGNOSTICS WERE WITHIN NORMAL LIMITS. X-RAY IMAGES WERE TAKEN AND SENT TO MFR FOR REVIEW ON (B)(6) 2011. THE ELECTRODES APPEARED TO BE ALIGNED PROPERLY. NO GROSS FRACTURE OR LEAD DISCONTINUITIES COULD BE VISUALIZED ON THE LEAD PORTION ASSESSED. GENERATOR COULD NOT BE ASSESSED IN THE X-RAY DUE TO THE LACK OF IMAGES OF THE CHEST. BASED ON THE X-RAYS RECEIVED THERE WERE NO ANOMALIES OBSERVED. HOWEVER, DUE TO THE LACK OF IMAGES AVAILABLE, THE ENTIRE LEAD BODY AND GENERATOR COULD NOT BE ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS INC 300-20 15270C

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention