BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2191564 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01604
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CONCLUSIONS: 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 PHYSICIAN THAT THE PT'S DEVICE HAD A HIGH IMPEDANCE. THERE WAS NO REPORT OF TRAUMA OR MANIPULATION, AND THE PT WAS NOT EXPERIENCING ANY ADVERSE EVENTS. X-RAYS OF THE DEVICE WERE SENT TO THE MFR FOR REVIEW, AND THE DEVICE WAS THEN DISABLED. THE X-RAYS SHOWED THAT THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED, THE FILTER FEEDTHRU WIRES APPEARED INTACT, AND THE LEAD WIRES APPEARED INTACT AT THE CONNECTOR PIN. THE LEAD BODY WAS ALSO ABLE TO BE VISUALIZED, AND NO OBVIOUS DISCONTINUITIES WERE OBSERVED. THE PT'S LAST KNOWN SETTINGS WERE GIVEN ON (B)(6) 2010. NORMAL MODE AND SYSTEM DIAGNOSTICS WERE NORMAL ON THIS DATE. A REVISION SURGERY IN THE FUTURE IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 011537

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR