BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3912686 · Received July 3, 2014

    Report

    Report Number
    1644487-2014-01688
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    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

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

    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

    ANALYSIS OF THE LEAD WAS COMPLETED ON 08/05/2014. SCANNING ELECTRON MICROSCOPY IMAGES OF THE BROKEN COILS AND STRAND SEGMENTS SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE COILS ENDS. A SEGMENT OF A STRAND WAS NOTED AT THE CENTER OF COIL 1. HOWEVER, DUE TO METAL DISSOLUTION, MECHANICAL DISTORTION (SMOOTHED SURFACES) AND /OR SURFACE CONTAMINATION THE FRACTURE MECHANISM OF THE COILS CANNOT BE DETERMINED. ABRASIONS WERE NOTED ON THE SILICONE TUBING OF THE LEAD COILS AT APPROXIMATELY 0.4-2.8CM PAST THE ELECTRODE BIFURCATION. A SUSPECTED COIL BREAK WAS IDENTIFIED AT THE END OF BOTH LEAD COILS LOCATED AT APPROXIMATELY 2.8CM PAST THE ELECTRODE BIFURCATION. THE SILICONE TUBING APPEARS TO HAVE BEEN TORN AT THIS LOCATION. TWO STRANDS SEGMENTS BECAME DETACHED FROM THE END OF COIL 2 DURING INSPECTION OF THE BROKEN END. THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENING AND THE ENDS OF THE RETURNED LEAD PORTIONS. INCISIONS IN THE SILICONE TUBING OF THE LEAD WERE NECESSARY TO PERFORM PROPER INSPECTION OF THE COILS. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE RETURNED LEAD IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO HIGH IMPEDANCE. PRE-OPERATIVE NORMAL MODE AND SYSTEM DIAGNOSTICS REVEALED HIGH IMPEDANCE. WHEN THE SURGEON OPENED THE NECK INCISION SITE, HE OBSERVED THAT THE LEAD BODY WAS IN TWO PIECES NEAR THE BIFURCATION. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389389 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200520

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR