BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3023602 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00812
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED, BUT A SUSPICIOUS AREA WAS NOTED SUGGESTING A POSSIBLE BREAK.DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE HIGH IMPEDANCE HAD BEEN OBSERVED ON (B)(6) 2013 AND THE IMPEDANCE VALUE WAS 5400OHMS. THE PATIENT WAS REFERRED FOR SURGERY. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH LEAD IMPEDANCE WAS DETECTED ON (B)(6) 2013 AND THE VNS GENERATOR'S OUTPUT CURRENT WAS DISABLED. IT WAS REVEALED THAT A VNS LEAD REVISION IS LIKELY BUT IT HAS NOT OCCURRED TO DATE. X-RAYS WERE REVIEWED BY THE MANUFACTURER BUT DUE TO THE IMAGE QUALITY NO ANOMALIES WERE CLEARLY VISIBLE. A SUSPECTED PORTION OF THE LEAD APPEARED TO BE MISSING IN THE IMAGE. IT COULD BE A DISCONTINUATION OF THE LEAD OR THE LEAD IN THAT AREA IS NOT VISIBLE DUE TO THE IMAGE QUALITY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT UNDERWENT FULL REVISION ON THAT DAY. HIGH IMPEDANCE WAS SEEN DURING THE PRE-OPERATIVE DIAGNOSTICS. THE EXPLANTED DEVICES ARE NOT EXPECTED FOR RETURN AS THE EXPLANTING FACILITY DOES NOT RETURN PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125851 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200431

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR