BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3191413 · Received June 26, 2013

    Report

    Report Number
    1644487-2013-01935
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    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 OCCURED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS FOR THIS PATIENT¿S EXPLANTED LEAD WAS APPROVED ON (B)(4) 2013. THE OUTER AND THE INNER SILICONE TUBING ARE ABRADED OPEN EXPOSING PORTIONS OF THE POSITIVE AND NEGATIVE LEAD COILS. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE EXPOSED AREA. SCANNING ELECTRON MICROSCOPY IMAGES THE POSITIVE AND NEGATIVE LEAD COILS SHOW THAT THE COILS HAVE WEAR (FLAT SURFACES) ON THE EXPOSED AREAS. THE LEAD ASSEMBLY HAS REMNANT OF WHAT APPEARS 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 END OF THE RETURNED LEAD PORTIONS. 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 TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. ANALYSIS OF THE GENERATOR SHOWED THAT 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. THE DEVICE WAS FOUND TO BE AT NORMAL END OF SERVICE AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013. THE SYSTEM WAS REPLACED DUE TO A CAR ACCIDENT. THE PATIENT PREVIOUSLY REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED DUE TO BEING AT END OF SERVICE. IT WAS ALSO SUGGESTED THAT THE PATIENT MAY HAVE A LEAD BREAK BECAUSE THE PATIENT WAS IN A MAJOR CAR ACCIDENT IN 2006 AND HAD NOT FELT STIMULATION SINCE THE ACCIDENT. THE PATIENT HAD NOT SEEN ANYONE TO GET THE DEVICE CHECKED AFTER THE ACCIDENT. NO X-RAYS HAVE BEEN TAKEN. REVIEW OF PROGRAMMING HISTORY SHOWED THAT THE PATIENT¿S DEVICE HAD BEEN INTERROGATED MULTIPLE TIMES IN AND AFTER THE 2006 CAR ACCIDENT. SYSTEM DIAGNOSTICS ON (B)(6) 2006, AND (B)(6) 2007 ALL INDICATE COMMUNICATION: OK, OUTPUT STATUS: OK, IMPEDANCE: OK (DCDC=3), AND BATTERY STATUS: NO. THE PATIENT¿S DEVICE WAS LAST PROGRAMMED ON (B)(6) 2009 TO 2.25/30/500/30/3. A BATTERY LIFE CALCULATION RETURNED 0 YEARS REMAINING. CLINIC NOTES WERE DATED (B)(6) 2012 INDICATED THAT THE PATIENT TYPICALLY HAS 2-4 SEIZURES PER MONTH. THE PATIENT REPORTED NO BENEFIT WITH VNS; HOWEVER, IT WAS UNCERTAIN IF THE SETTINGS WERE TITRATED. SINCE (B)(6) 2012, THE PATIENT EXPERIENCED 11 SEIZURES, WITH TWO OCCURRING IN ONE DAY. ATTEMPTS TO INTERROGATE THE PATIENT¿S DEVICE WERE UNSUCCESSFUL BECAUSE BATTERY WAS EXPIRED. THE PHYSICIAN NOTED THAT THE BATTERY COULD BE REPLACED AND SETTINGS TITRATED UP TO ATTEMPT IMPROVED SEIZURE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291451 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 011252

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR