BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 2193144 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01629
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: 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

    A PHYSICIAN'S OFFICE REPORTED THAT THE PT HAD RECEIVED A HIGH IMPEDANCE ON DIAGNOSTIC TESTING. THE PT'S LAST KNOWN SETTINGS WERE FROM (B)(6) 2010. THE PT WAS SENT FOR X-RAYS, WHICH DID NOT SHOW ANY ANOMALIES AFTER REVIEW BY THE MFR. THERE WAS NO KNOWN TRAUMA TO THE PT. DUE TO VOCAL CORD PARALYSIS ON THE PT LEFT AND RIGHT VOCAL CORDS FROM A NEONATAL STROKE, THE PHYSICIAN IS NOT WILLING TO PERFORM A LEAD REVISION SURGERY, ONLY A GENERATOR ONE. FURTHERMORE, THE PT MAY REQUIRE A TRACHEA TUBE. THE PT IS CURRENTLY SEIZURE FREE AND NOT TAKING ANY MEDICATIONS. THE MOTHER OF THE PT DECIDED TO PROCEED WITH A SECOND OPINION BEFORE SCHEDULING A SURGERY. A SURGERY IN THE FUTURE IS POSSIBLE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR