BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3232148 · Received July 17, 2013

    Report

    Report Number
    1644487-2013-02164
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 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
    UK
    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

    REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR LEAD PRIOR TO DISTRIBUTION. NO NONCONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT HAS HIGH IMPEDANCE AND X-RAYS WERE PERFORMED THAT SHOWED A CLEAR LEAD BREAK. THE X-RAYS WERE NOT SENT TO THE MANUFACTURER FOR REVIEW. THE PATIENT UNDERWENT REVISION SURGERY THAT DAY. IT WAS LATER REPORTED THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED IN (B)(6) 2013. THE PATIENT¿S DEVICE WAS NOT PROGRAMMED OFF DESPITE THE HIGH IMPEDANCE. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED TO THE MANUFACTURER ON (B)(4) 2013 FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTION. NOTE THAT A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS THE (+) CONNECTOR RING QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 252 MM FROM THE END OF THE CONNECTOR BOOT. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. DURING THE VISUAL ANALYSIS THE END OF THE (+) CONNECTOR RING QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 29 MM PAST THE END OF THE ABRADED OPEN / CUT OUTER SILICONE TUBING. THE (-) CONNECTOR PIN QUADFILAR COIL EXTENDED APPROXIMATELY 192 MM PAST THE END OF THE ABRADED OPEN / CUT OUTER SILICONE TUBING AND DETERMINATION COULD NOT BE MADE AS TO WHETHER THE END OF THE COIL WAS PULLED AND CUT. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE (+) CONNECTOR RING QUADFILAR COIL BREAK (FOUND AT 29 MM) AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE (-) CONNECTOR PIN QUADFILAR COIL (FOUND AT 192 MM) AND IDENTIFIED THE AREA ON TWO OF THE COIL STRANDS AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE WITH MECHANICAL DAMAGE AND NO PITTING. DETERMINATION COULD NOT CONCLUSIVELY BE MADE ON THE FRACTURE MECHANISM ON THESE TWO COIL STRANDS. THE AREA ON A THIRD COIL STRAND WAS IDENTIFIED AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (TENSION OVERLOAD). THE FOURTH QUADFILAR COIL STRAND WAS IDENTIFIED AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE, NO PITTING AND EVIDENCE OF A STRESS INDUCED FRACTURE (TORSIONAL APPEARANCE) WHICH MOST LIKELY COMPLETED THE FRACTURE. 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 SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS FOUND INSIDE THE OUTER SILICONE TUBING. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THERE WAS NO OBVIOUS PATH FOR FLUID INGRESS OTHER THAN THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS AND THE ABRADED OPENING OBSERVED ON THE CONNECTOR RING INNER SILICONE TUBING. 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 AND SULPHUR. REFER TO ATTACHED EDS SHEET FOR ADDITIONAL INFORMATION. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITIES, THE CONDITION OF THE RETURNED LEAD PORTION 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 PORTION 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 PORTION OF THE DEVICE. THE PULSE GENERATOR WAS EXPLANTED AND RETURNED FOR PRODUCT ANALYSIS DUE TO PROPHYLACTIC REPLACEMENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.942 VOLTS AS MEASURED DURING COMPLETION OF TEST PARAMETER 7.16.10.2 (MEASURED DIAGVBAT) OF THE FINAL ELECTRICAL TEST, SHOWS A-NON IFI CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 21.081% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330780 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200185

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR