BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR LEAD

    MDR report key: 1022086 · Received March 28, 2008

    Report

    Report Number
    1644487-2008-00809
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULT: X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CONCLUSION: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT ON PATIENT'S RECENT OFFICE VISIT, SYSTEM AND NORMAL MODE DIAGNOSTICS HAD RESULTED IN HIGH IMPEDANCE WITH DCDC=7. NO ADVERSE EVENTS WERE REPORTED BY THE PT. ADDITIONALLY, X-RAYS WERE REVIEWED BY THE MANUFACTURER. THREE TIE-DOWNS WERE VISUALIZED AND THE PLACEMENT OF THE GENERATOR WAS NORMAL. THE CONNECTOR PIN(S) DID NOT APPEAR TO BE FULLY INSERTED IN THE CONNECTOR BLOCK, WHICH MAY BE A POTENTIAL CAUSE FOR THE HIGH IMPEDANCE RESULTS. THE FILTER FEEDTHROUGHS APPEARED INTACT. THE STRAIN RELIEF LOOP WAS VISUALIZED; HOWEVER, THE MANUFACTURER WAS UNABLE TO ASSESS WHETHER THE STRAIN RELIEF BEND WAS PRESENT DUE TO THE QUALITY OF THE X-RAYS. A PORTION OF THE LEAD WAS BEHIND THE GENERATOR, AND THEREFORE THIS PORTION COULD NOT BE ASSESSED. NO LEAD DISCONTINUITIES AND ACUTE ANGLES WERE IDENTIFIED ON THE PORTIONS OF THE LEAD THAT WERE VISUALIZED. HOWEVER, THE ELECTRODE REGION AND STRAIN RELIEF BEND COULD NOT BE ASSESSED DUE TO THE CONTRAST OF THE X-RAY. IN ADDITION, IT WAS REPORTED THAT THE PT HAD FALLEN AND WAS INVOLVED IN A MINOR CAR ACCIDENT JUST PRIOR TO THE DISCOVERY OF THE HIGH IMPEDANCE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR LEAD NONE LYJ CYBERONICS, INC. 302-30 6267

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR