BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2191580 · Received July 20, 2011

    Report

    Report Number
    1644487-2011-01643
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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 CO REP THAT HIGH IMPEDANCE (7/LIMIT/HIGH) WAS RECEIVED AT AN OFFICE VISIT WITH THE TREATING NEUROLOGIST UPON INTERROGATION OF A PT'S GENERATOR AND DURING BOTH SYSTEM AND NORMAL MODE DIAGNOSTICS. THE LAST KNOWN GOOD DIAGNOSTICS WERE FROM (B)(6), 2010. IN ADDITION, THE PT'S MOTHER REPORTED CHANGES IN CONDUCT AND ALSO THAT THE MAGNET WAS NOT SO EFFECTIVE AS A RESULT OF HIGH IMPEDANCE. CURRENT INTERVENTIONS ARE TO PERFORM AN EVOKED POTENTIALS AND X-RAYS. FURTHER INFO WAS RECEIVED FROM A CO REP INDICATING THAT THE PT'S VNS WAS NOT PROGRAMMED OFF DUE TO THE HIGH LEAD IMPEDANCE. HOWEVER, THE DR HAS BEEN TRAINED REGARDING THE MFR'S RECOMMENDATIONS. NO PT TRAUMA OR MANIPULATION WAS REPORTED TO HAVE CONTRIBUTED TO THE HIGH LEAD IMPEDANCE. A FLUOROSCOPY PICTURE OF THE NECK AREA WAS SENT AND IT REVEALED THE ELECTRODES TO BE PLACED IN NORMAL ORIENTATION. THE PRESENCE OF A LEAD DISCONTINUITY COULD NO T BE EVALUATED AS THE RESOLUTION OF THE EXAM WAS POOR QUALITY. AT THE MOMENT NO SURGICAL INTERVENTIONS HAVE BEEN PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 2086

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male