BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3231930 · Received July 17, 2013

    Report

    Report Number
    1644487-2013-02153
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 21, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS ON (B)(4) 2013. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2013. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. 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 THE VNS PATIENT¿S DEVICE HAD A LEAD FRACTURE. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE AVAILABLE DATA. THE RESULT REVEALED 0.0 YEARS REMAINING UNTIL END OF SERVICE = YES. THE MANUFACTURING RECORDS FOR THE GENERATOR AND LEAD WERE REVIEWED AND DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. IT WAS LATER REPORTED THAT THE LEAD FRACTURE WAS IDENTIFIED ON (B)(6) 2013 BY X-RAY. THE PATIENT WAS PREVIOUSLY SEEN IN 2012 AND NO LEAD IMPEDANCE ISSUES WERE NOTED. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE LEAD FRACTURE. LEAD AND GENERATOR WERE REPLACED ON (B)(6) 2013. ATTEMPTS FOR RETURN OF THE EXPLANTED DEVICES ARE IN PROGRESS.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS AND THE REPORTED HIGH IMPEDANCE AND LEAD FRACTURE WERE CONFIRMED. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS OF THE RETURNED 335MM PORTION THE (-) CONNECTOR PIN AND (+) CONNECTOR RING QUADFILAR COILS APPEARED TO BE BROKEN. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE (+) CONNECTOR RING QUADFILAR COIL BREAK (FOUND AT 270MM) AND IDENTIFIED THE AREA ON ONE OF THE BROKEN QUADFILAR COIL STRANDS AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE AND PITTING ON THE COIL SURFACE. THE AREA ON ANOTHER BROKEN COIL STRAND WAS IDENTIFIED AS BEING MECHANICALLY DAMAGED WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE WITH PITTING. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE (-) CONNECTOR PIN QUADFILAR COIL BREAK (FOUND AT 284MM) AND IDENTIFIED THE AREA AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE, FINE PITTING AND EVIDENCE OF A STRESS INDUCED FRACTURE (TORSIONAL APPEARANCE) WHICH MOST LIKELY COMPLETED THE FRACTURE. PITTING WAS OBSERVED ON THE COIL SURFACE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY WHICH MAY INCLUDE: MATERIAL FRACTURE, ROUGH OR PITTED SURFACE, THINNED MATERIAL THICKNESS, ELECTRO-ETCHING OR MATERIAL DISSOLUTION. THE ABRADED OPENINGS AND SLICE MARKS FOUND ON THE OUTER AND INNER SILICONE TUBES AND THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE REMNANTS OF WHAT APPEARED TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE OUTER AND INNER SILICONE TUBES. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED IN VARIOUS LOCATIONS. EDS (ENERGY DISPERSION SPECTROSCOPY ¿ PROVIDES CHEMICAL OR ELEMENT IDENTITY/COMPOSITION ANALYSIS) WAS PERFORMED AND IDENTIFIED THE DEPOSIT AS CONTAINING SILICON, PHOSPHORUS, SODIUM, MAGNESIUM, POTASSIUM, ZIRCONIUM, SULPHUR AND CALCIUM. REFER TO ATTACHED EDS SHEET FOR ADDITIONAL INFORMATION. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED EXCEPT FOR THE 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. 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. HOWEVER, BASED ON THE LOCATION OF THE SETSCREW MARKS ON THE PIN, IT IS UNKNOWN WHETHER A GOOD ELECTRICAL CONNECTION WAS PRESENT FOR THE CONNECTOR RING. CANTED SPRING MARKS WERE NOT OBSERVED ON THE REAR END OF THE SMALL O-RING. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS EVIDENCE TO SUGGEST DISCONTINUITIES IN THE RETURNED PORTIONS OF THE DEVICE. NOTE THAT SINCE THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331576 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302 1129

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR