BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1963653 · Received December 21, 2010

    Report

    Report Number
    1644487-2010-02860
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REP THAT HIGH LEAD IMPEDANCE WAS DISCOVERED ON A VNS PT BY A SURGEON. THE SURGEON INDICATED THAT THE HIGH LEAD IMPEDANCE (7/LIMIT/HIGH) HAD BEEN PRESENT SINCE (B)(6) 2010 BUT HAD NOT BEEN REPORTED TO THE MFR. F/U WAS MADE WITH THE PT'S TREATING NEUROLOGIST AND INFO FROM THE NEUROLOGIST REVEALED THE LAST KNOWN GOOD DIAGNOSTICS WERE PERFORMED BACK IN 2008 AND WERE MARKED AS NORMAL. THE NEUROLOGIST DID NOT SUSPECT ANY PT MANIPULATION OR TRAUMA TO THE DEVICE AND SHE DID NOT PROGRAM THE PT OFF DUE TO THE HIGH LEAD IMPEDANCE. X-RAYS WERE TAKEN BUT WERE NOT GOING TO BE PROVIDED. THE PHYSICIAN'S X-RAY EVAL WAS ALSO NOT PROVIDED. THE PT UNDERWENT FULL REVISION SURGERY AS SCHEDULED AND GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED DEVICES 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 1214

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR