BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3103424 · Received May 9, 2013

    Report

    Report Number
    1644487-2013-01298
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION; CORRECTED DATA: INCORRECTLY REPORTED ON SUPPLEMENTAL MFR. REPORT #2 DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY. MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, LEAD DISCONTINUITY VISUALIZED. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2013. IT WS REPORTED THAT THE LEAD WAS REPLACED. THE LEAD WAS RETURNED TO MANUFACTURER FOR ANALYSIS ON (B)(4) 2013. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, HIGH IMPEDANCE WAS REPORTED. THE PATIENT CAME IN FOR FOLLOW-UP ON (B)(6) 2013 DUE TO AN INCREASE IN SEIZURE FREQUENCY. A NORMAL MODE AND SYSTEM DIAGNOSTIC SHOWED HIGH IMPEDANCE (DCDC=7). THE PHYSICIAN BELIEVED THE INCREASE IN SEIZURES WAS RELATED TO THE HIGH IMPEDANCE. THE PHYSICIAN STATED THAT HIGH IMPEDANCE WAS PREVIOUSLY SEEN DURING NORMAL MODE DIAGNOSTICS BUT NOT SYSTEM DIAGNOSTICS; THEREFORE, THE PHYSICIAN BELIEVED FIBROSIS WAS THE CAUSE. AT THAT TIME, THE OUTPUT CURRENT WAS REDUCED AND THE DUTY CYCLE WAS INCREASED. THE PHYSICIAN NOW SUSPECTED FIBROSIS OR A LEAD BREAK. X-RAYS WERE TAKEN ON (B)(6) 2013. FOLLOW-UP SHOWED THAT THE INCREASE IN SEIZURES WAS ALMOST BACK TO PRE-VNS LEVELS BUT SLIGHTLY BETTER. THE DEVICE WAS NOT DISABLED. NO MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. A PHYSICIAN REVIEWED OF X-RAYS DID NOT NOTICE A BREAK OR DISCONNECTION THE LEAD WAS NOTED TO BE ¿LOOKING WEIRD.¿ A.P. AND LATERAL CHEST X-RAYS WERE RECEIVED. THE GENERATOR APPEARS IN THE UPPER LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN¿S INSERTION INTO THE GENERATOR CONNECTOR BLOCK COULD NOT BE FULLY ASSESSED DUE TO THE QUALITY OF THE IMAGES. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. PART OF THE LEAD WAS BEHIND THE GENERATOR. NO ACUTE ANGLE WAS FOUND, BUT A LEAD DISCONTINUITY WAS NOTED IN THE PATIENT¿S NECK AREA, WITHIN THE STRAIN-RELIEF LOOP. A REVIEW OF PROGRAMMING HISTORY SHOWED SETTINGS AND A SYSTEM DIAGNOSTIC FROM (B)(6) 2012. A NORMAL MODE DIAGNOSTIC FROM 10/31/2012 INDICATED HIGH IMPEDANCE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    THE LEAD ANALYSIS WAS COMPLETED ON 11/12/2013. DURING THE VISUAL ANALYSIS TWO BROKEN COIL STRANDS WERE OBSERVED ON THE (+) WHITE ELECTRODE QUADFILAR COIL APPROXIMATELY 14MM FROM THE ELECTRODE BIFURCATION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA ON ONE OF THE BROKEN COIL STRANDS AS BEING MECHANICALLY DAMAGED WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE AND NO PITTING. THE REMAINING BROKEN COIL STRAND WAS IDENTIFIED AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE (FATIGUE APPEARANCE) WITH MECHANICAL DAMAGE AND NO PITTING. DURING THE VISUAL ANALYSIS THE (-) GREEN ELECTRODE QUADFILAR COIL APPEARED TO BE BROKEN AT THE PROXIMAL END OF THE ANCHOR TETHER. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS BEING MECHANICALLY DAMAGED WITH PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. PITTING WAS OBSERVED ON THE COIL SURFACE. DETERMINATION COULD NOT CONCLUSIVELY BE MADE ON THE FRACTURE MECHANISM. 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 SLICE MARKS 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. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED EXCEPT FOR THE SETSCREW MARKS OBSERVED NEAR THE END OF THE CONNECTOR PIN, INDICATING THE CONNECTOR PIN HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE PULSE GENERATOR AT ONE TIME. BASED ON THE LOCATION OF THE SETSCREW MARKS ON THE PIN, IT IS UNKNOWN WHETHER A GOOD ELECTRICAL CONNECTION WAS PRESENT FOR THE CONNECTOR RING. CONTINUITY CHECKS OF THE RETURNED LEAD ASSEMBLY WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT WILL HAVE LEAD REVISION SURGERY BUT NO DATE SET AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203298 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 201010

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR