BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2191851 · Received July 22, 2011

    Report

    Report Number
    1644487-2011-01667
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 27, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REP THAT A VNS PT WAS SEEN AT AN OFFICE VISIT IN WHICH HIGH LEAD IMPEDANCE (DC DC 7) WAS IDENTIFIED. THE LAST KNOWN SETTINGS WERE FROM (B)(6) 2011. THE PT WAS REFERRED FOR X-RAYS AND THE GENERATOR WAS PROGRAMMED OFF. X-RAYS WERE RECEIVED AND REVIEWED BY THE MFR. REVIEW OF X-RAYS INDICATED THAT THE GENERATOR PLACEMENT APPEARED TO BE NORMAL AND THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN APPEARED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. MOST OF THE LEAD WAS FOUND TO BE COILED NEAR THE CHEST AREA IN A CONDITION EXHIBITED BY A "TWIDDLER." A LEAD DISCONTINUITY WAS FOUND IN THE CHEST AREA BASED ON THE COILING OF THE LEAD. AT THE MOMENT, GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO LEAD DISCONTINUITY. THE EXPLANTING FACILITY DISCARDED THE EXPLANTED DEVICES; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN THAT NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT COULD HAVE CONTRIBUTED TO THE REPORTED HIGH LEAD IMPEDANCE. THE SURGERY FOR LEAD REVISION HAS NOT BEEN SCHEDULED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 009894

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR