BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3854192 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01427
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    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.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED LEAD PORTION WAS COMPLETED. NO DISCONTINUITIES WERE IDENTIFIED WITHIN THE RETURNED LEAD PORTION. THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS/BETADINE SOLUTION INSIDE THE INNER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE END OF THE RETURNED LEAD PORTIONS. INCISIONS IN THE SILICONE TUBING OF THE RETURNED LEAD PORTIONS WERE NECESSARY TO PERFORM PROPER INSPECTION OF THE LEAD COILS. THE IN-LINE LEAD CONNECTOR HAS SINGLE SETSCREW MARK AT THE END TIP OF THE CONNECTOR PIN SUGGESTING THAT THE LEAD CONNECTOR WAS NOT INSERTED COMPLETELY AT ONE POINT IN TIME. THE EXACT POINT IN TIME OF WHEN THIS OCCURRED IS UNKNOWN. ALTHOUGH NOT CONCLUSIVE, THIS CONDITION MAY CONFIRM TO BE A CONTRIBUTING FACTOR TO THE REPORTED HIGH IMPEDANCE. BASED IN THE LOCATION OF THE ONE COMPLETE SET OF SETSCREW MARKS PRESENT ON THE CONNECTOR PIN AND SCRATCHES FROM THE CANTED SPRING OBSERVED ON THE CONNECTOR RING, IT IS BELIEVED THAT PROPER CONTACT BETWEEN THE PULSE GENERATOR ¿+¿ AND ¿¿¿ TERMINALS AND THE LEAD CONNECTOR RESPECTIVE CONTACT POINTS (CONNECTOR RING AND CONNECTOR PIN) EXISTED AT LEAST ONCE. THE LEAD CONNECTOR WAS INSERTED COMPLETELY IN A REPRESENTATIVE PULSE GENERATOR HEADER AND NO ANOMALIES THAT COULD PREVENT PROPER INSERTION WERE IDENTIFIED. 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 ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEAD REPLACEMENT SURGERY. DEVICE DIAGNOSTICS WITH THE NEW LEAD ATTACHED TO THE EXISTING GENERATOR WAS WITHIN NORMAL LIMITS (1600 OHMS). THE EXPLANTED LEAD WAS RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE. THE PATIENT HAD RECENTLY UNDERGONE GENERATOR REPLACEMENT. DEVICE PROGRAMMING HISTORY WAS RECEIVED FROM THE HANDHELD USED DURING SURGERY WHICH INDICATED THAT THE HIGH IMPEDANCE WAS PRESENT WITH THE NEW GENERATOR ATTACHED TO THE EXISTING LEAD. CLINIC NOTES DATED (B)(6) 2014 NOTE THAT HIGH IMPEDANCE WAS OBSERVED AND THAT THE PATIENT WOULD BE REFERRED TO SURGEON. THE NOTES INDICATE THAT DURING THE GENERATOR REPLACEMENT SURGERY THE BATTERY WAS FUNCTIONING APPROPRIATELY; HOWEVER, THE LEAD IMPEDANCE CONTINUALLY RETURNED ELEVATED. IT WAS NOTED THAT THE EXPLANTED GENERATOR WAS DEAD; THEREFORE THE HIGH IMPEDANCE WAS NOT OBSERVED PRIOR TO GENERATOR REPLACEMENT. THE PATIENT IS SCHEDULED FOR SURGERY TO CORRECT THE HIGH IMPEDANCE; HOWEVER, THE SURGERY HAS NOT OCCURRED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331192 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 2164

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR