BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1961071 · Received January 12, 2011

    Report

    Report Number
    1644487-2011-00046
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT A VNS PT'S LEAD WIRE WAS BUNCHED UP NEAR THE GENERATOR AREA. THE NURSE INDICATED THE LEAD WAS NOTICABLE AND TRIED TO CONTACT THE NEUROSURGEON WHO RECENTLY PERFORMED A BATTERY CHANGE ON THE PT ((B)(6) 2010), BUT WAS UNABLE TO CONTACT THE SURGEON AS THE PHYSICIAN IS NO LONGER IN PRACTICE. X-RAYS WERE TAKEN OF THE PT AND WERE RECEIVED BY THE MFR. REVIEW OF THE X-RAYS INDICATED THE GENERATOR PLACEMENT APPEARED TO BE NORMAL, AND THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN APPEARED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE PLACEMENT OF THE ELECTRODES APPEARED TO BE IN NORMAL POSITIONING IN ACCORDANCE TO CYBERONICS LABELING. NO OBVIOUS LEAD DISCONTINUITIES OR ACUTE ANGLES WERE OBSERVED IN THE OBSERVED PORTIONS OF THE LEAD BODY THAT COULD BE ASSESSED. ALTHOUGH THERE WAS SOME LEAD BEHIND THE GENERATOR, MOST OF THE LEAD WAS LOCATED ABOVE THE GENERATOR IN THE CHEST AREA. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING NURSE HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 24638C

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention