BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2102236 · Received May 19, 2011

    Report

    Report Number
    1644487-2011-01119
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PATIENT WAS BEING EXPLANTED DUE TO THE VNS NO LONGER BEING DESIRED. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR ANALYSIS. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE LEAD COIL SHOWED THAT PITTING OR ELECTRO-ETCHING CONDITIONS OCCURRED AT THE POSITIVE COIL END. DUE TO METAL DISSOLUTION, THE FRACTURE MECHANISM COULD NOT BE DETERMINED. SCANNING ELECTRON MICROSCOPY OF THE NEGATIVE COIL BROKEN ENDS SHOWED THAT PITTING OR ELECTRO-ETCHING CONDITIONS OCCURRED AT THE BROKEN COIL ENDS. ALSO, ONE STRAND OF THE NEGATIVE QUADFILAR COIL SHOWED THE APPEARANCE CHARACTERISTIC OF A STRESS-INDUCED FRACTURE (FATIGUE). THERE WAS NO CONDITION NOTED DURING THE PRODUCT EVALUATION OF THE GENERATOR THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 11252

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR