BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3221025 · Received July 11, 2013

    Report

    Report Number
    1644487-2013-02073
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF LEAD WAS PERFORMED, WHICH CONFIRMED DISCONTINUITY OF POSITIVE QUADFILAR COIL IN THE BODY REGION OF THE RETURNED LEAD PORTION AND ALSO OBSERVED AN ABRADED OPENING OF THE OUTER AND BOTH INNER TUBING SECTIONS NEAR THE BREAK AREA ABRADED OPENINGS WERE NOTED ON THE OUTER AND THE INNER SILICONE TUBING. A BREAK WAS IDENTIFIED IN THE POSITIVE COIL. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS OCCURRED AT THE BREAK LOCATION. ALSO, THE MATING END OF THE POSITIVE COIL SHOWS APPEARANCE SUGGESTING THAT MECHANICAL DISTORTION (SMOOTHED SURFACES) OCCURRED AT THE BREAK. HOWEVER, DUE TO METAL DISSOLUTION AND/OR MECHANICAL DISTORTION (SMOOTHED SURFACES) THE FRACTURE MECHANISM CANNOT BE DETERMINED. ALSO, SCANNING ELECTRON MICROSCOPY IMAGES OF THE NEGATIVE COIL SHOW THAT PITTING OR ELECTRO¿ETCHING CONDITIONS HAVE OCCURRED AT THE AREA WHERE THE OPAQUE APPEARANCE WAS NOTED. 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 OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. THE OUTER SILICONE TUBING IS ABRADED OPEN AT APPROXIMATELY 5.3-6CM FROM BOOT. THE INNER SILICONE TUBING OF THE LEAD COILS IS ABRADED OPEN AT APPROXIMATELY 6.8CM (POSITIVE) AND 6.8-7CM (NEGATIVE, TWO SIDES) FROM THE END OF THE CONNECTOR BOOT. THE NEGATIVE COIL HAS AN OPAQUE APPEARANCE AT THE AREA WHERE THE INNER TUBING OPENING IS LOCATED. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEAR TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS AND THE ENDS OF THE RETURNED LEAD PORTION. PRODUCT ANALYSIS OF THE EXPLANTED GENERATOR FOUND THAT THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. PRODUCT ANALYSIS OF THE UNUSED GENERATOR WAS PERFORMED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.969 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 1.133% OF THE BATTERY HAD BEEN CONSUMED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT UNDERWENT A FULL REVISION SURGERY THAT DAY DUE TO PROPHYLACTIC GENERATOR REPLACEMENT AND A LEAD DISCONTINUITY. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 0.72 YEARS REMAINING UNTIL ERI=YES. IT WAS LATER REPORTED THAT DURING SURGERY WHEN THE PATIENT¿S NEW GENERATOR WAS IMPLANTED, HIGH IMPEDANCE WAS STILL OBSERVED; THEREFORE THE LEAD AND NEW GENERATOR WERE EXPLANTED. IT WAS STATED THAT THE LEAD WAS CLIPPED WHERE IT ATTACHES TO THE NERVE. NO REPLACEMENT DEVICES WERE IMPLANTED AT THE TIME. IT WAS REPORTED THAT THE SURGEON HAD ATTEMPTED TO DO A FULL REVISION SURGERY ON DATE OF SURGERY BUT WAS UNSUCCESSFUL. HE HAD TRIED TO FULLY REMOVE THE LEAD AT THE NECK INCISION BUT THE SCAR TISSUE WAS TOO ENVELOPED. THE PATIENT¿S MOTHER ELECTED TO WAIT FOR ANOTHER ATTEMPT. THE NURSE PRACTITIONER NOTED THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(6) 2013. THE DEVICE WAS NOT PROGRAMMED OFF DESPITE THE HIGH IMPEDANCE. X-RAYS WERE TAKEN PRIOR TO SURGERY BUT SHE REPORTED THAT THEY WOULD NOT BE SENT TO THE MANUFACTURER FOR REVIEW. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. A LEAD FRACTURE WAS NOT OBSERVED DURING SURGERY. THE EXPLANTED LEAD AND TWO GENERATORS WERE RETURNED FOR PRODUCT ANALYSIS ON (B)(4), 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319500 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200631

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR