BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3212870 · Received July 9, 2013

    Report

    Report Number
    1644487-2013-02049
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(6 2013 INDICATED THAT THIS VNS PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013 DUE TO HIGH IMPEDANCE. ATTEMPTS FOR ADDITIONAL INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE EXPLANTED GENERATOR AND LEAD WERE AVAILABLE TO BE RETURNED FOR ANALYSIS. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON 11/06/2014. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. ANALYSIS OF THE LEAD IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT SYSTEM DIAGNOSTICS SHOWED HIGH IMPEDANCE. THERE WAS NO REPORTED TRAUMA OR MANIPULATION. THE DEVICE WAS NOT PROGRAMMED OFF AS THE PHYSICIAN PREFERRED TO KEEP THE DEVICE ON. THE PATIENT HAD BEEN EXPERIENCING AN INCREASED IN SEIZURES FOR THE PAST SEVERAL WEEKS BUT WAS IMPROVED AFTER VNS IMPLANT. X-RAYS WERE RECEIVED AND REVIEWED. THE GENERATOR APPEARS IN THE UPPER LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. IT CANNOT BE CONFIRMED THAT THE LEAD PIN IS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT, BUT THE NEGATIVE ONE SEEMED TO BE NOT ALIGNED WITH THE POSITIVE ONE. THIS COULD BE CAUSED BY THE POSITION OF THE PATIENT¿S NECK AND IT CANNOT BE ASCERTAINED THAT IT IS DUE TO AN ELECTRODE DETACHMENT. PART OF THE LEAD WAS BEHIND THE GENERATOR. NO ACUTE ANGLES/BREAKS APPEAR TO BE PRESENT. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD WAS COMPLETED ON 11/18/2014. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED EXCEPT FOR THE ONE AND A HALF SET OF SETSCREW MARKS FOUND NEAR THE END OF THE CONNECTOR PIN INDICATING THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE GENERATOR AT ONE TIME. THE MARKS ARE EVIDENCE OF A POTENTIALLY INSUFFICIENT MECHANICAL CONTACT BETWEEN CONDUCTIVE SURFACES OF THE GENERATOR AND CONNECTOR RING, RESULTING IN A SUSPECT ELECTRICAL CONNECTION TO THE LEAD. WHAT APPEARED TO BE CANTED SPRING INDENTATIONS WERE OBSERVED NEAR THE END OF THE SMALL O-RING. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312599 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 201010

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR