BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2851904 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03154
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    April 1, 2012
    Report Date
    October 30, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    CLINIC NOTES WERE RECEIVED FOR REVIEW THAT REPORTED OVER THE PAST FEW MONTHS THERE HAS BEEN AN INCREASE IN SEIZURES, ALTHOUGH THE ACTUAL FREQUENCY IS NOT CLEAR. LEAD IMPEDANCE APPEARS TO BE SATISFACTORY; HOWEVER, THERE IS TENTING OF THE SKIN OVER THE LEAD. THE PATIENT WAS SCHEDULED FOR SURGERY TO FIND OUT IF THE LEAD NEEDS TO BE REPLACED OR IF IT CAN BE FREED UP. THEIR VNS WAS INTERROGATED AT THAT TIME BUT NO CHANGES WERE MADE TO THE SETTINGS ON ACCOUNT OF LOW BATTERY RESERVE. THE PATIENT CLINIC VISIT (B)(6) 2012 A LEAD TEST WAS PERFORMED THAT SHOWED OUTPUT STATUS OK, LEAD IMPEDANCE OK, DCDC 2, ERI NO. THEN LATER IN NOTES SAYS PATIENT DEVICE INTERROGATED AND BATTERY SHOWS NEAR END OF SERVICE AND NEEDS TO BE REPLACED. THE PATIENT'S SEIZURES WERE AT BASELINE AND NOT A CHANGE IN SEIZURE TYPE AND WERE BEING ATTRIBUTED TO THEIR LOW BATTERY. THE PATIENT HAD SURGERY FOR PATIENT COMFORT NOT TO PRECLUDE AN SERIOUS INJURY. THE PATIENT'S VNS BATTERY NEEDED REPLACING SOON BASED ON TIME IMPLANTED NOT ACTUAL BATTERY VOLTAGE. THEY WERE NOT AT EOS BUT SOON SO GOING TO THE O.R. FOR THAT AND ASSESSING THE OTHER ISSUE WITH TENTING OVER THE LEAD AT THAT TIME. THE PATIENT WENT TO SURGERY AND HAD THEIR GENERATOR REPLACED AND LEAD. THEIR LEAD WAS A PROPHYLACTIC REPLACEMENT. NO CAUSE OF THE TENTING WAS NOTED IN THE OR OTHER THAN PATIENT GROWTH. THE PATIENT WAS IMPLANTED WITH THEIR VNS WHEN 11 AND NOW 18. IT IS POSSIBLE PATIENT GROWTH HAS ATTRIBUTED TO THE REPORTED TENTING OVER THE LEAD BODY. IMPLANTED FOR OVER 7 YEARS. IMPEDANCES WERE WITHIN NORMAL LIMITS REPORTED AT THE TIME OF EXPLANT. A SECTION OF THE LEAD ASSEMBLY WAS RETURNED FOR ANALYSIS IN ONE PIECE.THE LEAD'S ELECTRODES WERE NOT RETURNED FOR EVALUATION. A COIL BREAK WAS IDENTIFIED IN THE NEGATIVE COIL. SCANNING ELECTRON MICROSCOPY OF THE NEGATIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE END OF THE COIL. HOWEVER, DUE TO METAL DISSOLUTION THE FRACTURE MECHANISM CANNOT BE DETERMINED. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL; SHOW THAT THE COIL WAS MOST LIKELY CUT USING SOME TYPE ELECTRO-CAUTERY TOOL AS INDICATED BY THE FUSED COIL WIRES AT THE COIL END. ALSO, SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL AT 1.1CM AND 1.4CM PAST THE ELECTRODE BIFURCATION VERIFIED THAT THE COIL WAS EXPOSED TO SOME TYPE ELECTRO-CAUTERY TOOL AS INDICATED BY THE APPEARANCE OF THE COIL WIRES. THESE CONDITIONS WERE MOST LIKELY CAUSED DURING THE EXPLANT PROCEDURE. THIS CANNOT BE VERIFIED. 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 PATIENT'S EXPLANTED GENERATOR WAS RETURNED FOR ANALYSIS. IN THE ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS OBSERVED ON AN OSCILLOSCOPE WHILE PROGRAMMED TO THE LAST KNOWN PARAMETERS FROM THE VNS PROGRAMMING HISTORY DATABASE (NO AS-RECEIVED PARAMETERS). THE GENERATORS CALCULATED OUTPUT VOLTAGE WAS 10.0 VOLTS (4K OHMS X 2.50MA), WITH AN ALLOWABLE +/- 10% TOLERANCE. THE GENERATORS OUTPUT VOLTAGE MEASURED 8.51 VOLTS. THE PULSE GENERATOR COULD NOT MAINTAIN THE PROGRAMMED OUTPUT DUE TO A DEPLETED BATTERY. THE REPORTED ALLEGATION OF "END OF SERVICE", WAS DUPLICATED IN THE LABORATORY AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION, BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. 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
    1 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 011406

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR