BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2983386 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00553
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 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, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE LEAD ANALYSIS WAS COMPLETED ON (B)(4) 2013. ANALYSIS OF THE LEAD SHOWED THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. VISUAL ANALYSIS OF THE RETURNED 309 MM PORTION SHOWED ABRADED OPENINGS ON THE OUTER AND INNER SILICONE TUBING IN SOME AREAS. VISUAL ANALYSIS FOUND THAT THE QUADFILAR COIL ONE APPEARED TO BE BURNT IN HALF IN THE BODY AREA OF THE RETURNED LEAD PORTION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE BURNT AREA AS HAVING THE APPEARANCE OF BEING MELTED, WITH RE-SOLIDIFIED MATERIAL (EVIDENCE OF BEING MELTED AT ONE TIME). BASED ON THE OBVIOUS SIGNS OF MECHANICAL DAMAGE ON THE COIL SURFACES, IT IS POSSIBLE THE THERMALLY-DAMAGED COILS WERE EXPOSED TO A HIGH TEMPERATURE DEVICE SUCH AS A CAUTERIZING TOOL (ELECTROSURGICAL UNIT) DURING THE EXPLANT OF THIS LEAD. DURING THE VISUAL ANALYSIS OF THE RETURNED 309 MM PORTION QUADFILAR COIL TWO APPEARED TO BE BROKEN APPROXIMATELY 211 MM FROM THE END OF THE CUT OUTER / INNER SILICONE TUBES. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE AND MECHANICAL DAMAGE. DURING THE VISUAL ANALYSIS OF THE RETURNED 309 MM PORTION QUADFILAR COIL TWO APPEARED TO BE BROKEN APPROXIMATELY 250 MM FROM THE END OF THE CUT OUTER / INNER SILICONE TUBES. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE, RESIDUAL MATERIAL AND NO PITTING. 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 FOUND ON THE OUTER AND INNER SILICONE TUBING TWO AND THE TORN ENDS OBSERVED ON BOTH OF THE INNER SILICONE TUBES, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER AND INNER SILICONE TUBES. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED ON THE CONNECTOR BOOT. EDS (ENERGY DISPERSION SPECTROSCOPY ¿ PROVIDES CHEMICAL OR ELEMENT IDENTITY/COMPOSITION ANALYSIS) WAS PERFORMED AND IDENTIFIED THE DEPOSIT AS CONTAINING SILICON, PHOSPHORUS, POTASSIUM, SULPHUR AND CALCIUM. 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. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT HAD THEIR LEAD REPLACED ON (B)(6) 2013 AND THEIR EXPLANTED PRODUCT HAS BEEN RETURNED FOR ANALYSIS. ANALYSIS COMPLETION IS PENDING.

    Description of Event or Problem · 1

    ON (B)(6) /2013, IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN DURING GENERATOR REVISION DUE TO END OF SERVICE. THE SURGEON PERFORMED A GENERATOR DIAGNOSTIC ON THE NEWLY IMPLANTED GENERATOR. THE GENERATOR WAS THEN RECONNECTED TO THE LEAD ENSURING THAT THE PIN WAS PAST THE CONNECTOR BLOCK AND FULLY INSERTED. DIAGNOSTICS AGAIN SHOWED HIGH IMPEDANCE. THE SURGEON INSPECTED THE PORTION OF THE LEAD THAT WAS ABLE TO BE VISUALIZED, AND A BREAK WAS SEEN WITH FLUID IN THE TUBING. THE LEAD WAS NOT REPLACED AT THIS TIME. NO PATIENT MANIPULATION OR TRAUMA WAS SUSPECTED, NO X-RAYS WERE TAKEN, AND THE EXPLANTED GENERATOR WAS DISCARDED. THE NEW GENERATOR WAS NOT PROGRAMMED ON. THE LAST KNOWN DIAGNOSTICS INDICATED A SYSTEM DIAGNOSTIC WITH DCDC=2 APPROXIMATELY TWO YEARS PRIOR. THE PATIENT WAS LOST TO FOLLOW-UP; HOWEVER, THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES SIX MONTHS PRIOR (BELOW BASELINE), AND THE RESIDENT GENERATOR COULD NOT BE INTERROGATED OR PROGRAMMED BECAUSE IT WAS AT END OF SERVICE. THE PATIENT COULD NOT FEEL NORMAL MODE OR MAGNET MODE STIMULATION. THE PATIENT'S PHYSICIAN BELIEVED THE INCREASE WAS DUE TO LOSS OF THERAPY. A BLC AT THIS TIME INDICATED NEGATIVE RESULTS. LEAD REVISION IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    NOTES FROM THE PATIENT'S (B)(6) 2013 SURGERY WERE RECEIVED ON (B)(4) 2013. THE DEVICE WAS REPORTEDLY NOT FUNCTIONING FOR SEVERAL YEARS. (THIS WAS CLARIFIED TO MEAN THE DEVICE WAS AT END OF SERVICE). IN SURGERY, THE GENERATOR WAS DISCONNECTED AND A NEW UNIT WAS CONNECTED TO THE EXISTING LEAD. TESTING SHOWED IMPEDANCE: THE DEVICE WAS RECHECKED AND RETESTED. INSPECTION OF THE LEAD SHOWED A LONGITUDINAL LINEAR SEPARATION IN THE PLASTIC AROUND THE METALLIC WIRES. WHILE THE WIRES THEMSELVES WERE GROSSLY INTACT AND THERE WAS NO SIDE OF DISCONNECT OR FRACTURE, THE SHEATH AROUND THE WIRES APPEARED TO HAVE BEEN WORN DOWN AND SPLIT IN A LINEAR DISTRIBUTION. THE PLASTIC ITSELF APPEARED TO HAVE ERODED AWAY FROM THE WIRES. THE LEAD WAS NOT REPLACED AT THIS TIME. THE GENERATOR WAS SEWN INTO PLACE. LEAD REVISION IS STILL LIKELY BUT HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86729 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 011190

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR