BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2885140 · Received December 26, 2012

    Report

    Report Number
    1644487-2012-03446
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. ANALYSIS OF PROGRAMMING HISTORY. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED BY PHYSICIAN, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR AND LEAD. THE GENERATOR OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24 HOURS WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT, WITH RESULTS SHOWING NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. VISUAL EXAMINATION NOTED TOOL MARKS ON THE PULSE GENERATOR CASE, MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE AS THE MARKINGS ARE CONSISTENT WITH DEVICES TYPICALLY USED IN A SURGICAL PROCEDURE (FORCEPS, ETC.) THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. A SMALL PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. ADDITIONALLY ONE LOOSE TIE DOWN WAS RETURNED. DURING THE VISUAL ANALYSIS PITTING WAS OBSERVED ON THE SURFACE OF THE CONNECTOR PIN. SEM WAS PERFORMED AND IDENTIFIED EVIDENCE OF BEING MELTED AND PITTING ON THE SURFACE OF THE CONNECTOR PIN. ENERGY DISPERSION SPECTROSCOPY (EDS) WAS PERFORMED ON THE CONNECTOR PIN PITTED AND IDENTIFIED THE AREA AS CONTAINING CHROMIUM, IRON, NICKEL, MANGANESE, SILICON, AND MOLYBDENUM. EDS WAS PERFORMED ON THE CLEAN SURFACE OF THE CONNECTOR PIN AND IDENTIFIED THE AREA AS CONTAINING CHROMIUM, IRON, NICKEL, AND MOLYBDENUM. ANOTHER EDS WAS PERFORMED ON THE MELTED SURFACE OF THE CONNECTOR PIN AND IDENTIFIED THE AREA AS CONTAINING CHROMIUM, IRON, NICKEL, MANGANESE, PHOSPHOROUS, AND MOLYBDENUM. IT IS UNKNOWN WHAT CAUSED THE MELTED APPEARANCE ON THE CONNECTOR PIN SURFACE. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED IN VARIOUS LOCATIONS. EDS WAS PERFORMED AND IDENTIFIED THE DEPOSITS AS CONTAINING SODIUM, SILICON, PHOSPHOROUS, ZIRCONIUM, AND CALCIUM. UPON VISUAL INSPECTION OF THE GENERATOR CAVITY NO ANOMALIES WERE OBSERVED. DURING THE VISUAL ANALYSIS THE QUADFILAR COILS APPEARED TO BE STRETCHED, WAVY AND SPIRALED, IN SOME AREAS. THE CONNECTOR RING QUADFILAR COIL APPEARED TO BE BURNT IN HALF. SEM WAS PERFORMED AND IDENTIFIED THE BURNT AREAS AS HAVING THE APPEARANCE OF BEING MELTED, WITH RE-SOLIDIFIED MATERIAL (EVIDENCE OF BEING MELTED AT ONE TIME). IT IS UNKNOWN EXACTLY WHAT CAUSED THE QUADFILAR COILS TO MELT. BASED ON THE OBVIOUS SIGNS OF MECHANICAL DAMAGE ON THE COIL SURFACES, IT IS POSSIBLE THE OPENINGS ON THE OUTER AND INNER SILICONE TUBES AND THE THERMALLY-DAMAGED COILS WERE EXPOSED TO A HIGH TEMPERATURE DEVICE SUCH AS A CAUTERIZING TOOL DURING THE EXPLANT OF THIS LEAD. THE ABRADED OPENING FOUND ON THE OUTER SILICONE TUBING, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS INSIDE THE OUTER SILICONE TUBING. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THE OBSERVED LOCATION OF THE BARE TOUCHING COILS MAY HAVE BEEN A POSSIBLE CAUSE. WITH THE EXCEPTION OF THE OBSERVED MELTED AREAS ON THE CONNECTOR PIN AND BOTH OF THE QUADFILAR COILS THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH THAT WHICH TYPICALLY EXISTS FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS OF THE PA, THERE IS NO EVIDENCE TO SUGGEST DISCONTINUITIES IN THE RETURNED PORTION OF THE DEVICE. THE OBSERVED INNER TUBING OPENINGS WHERE BARE COILS WERE TOUCHING COULD HAVE POTENTIALLY CONTRIBUTED TO THE LOW IMPEDANCE AND SUSPECTED SHORT CIRCUIT CONDITION. NOTE THAT SINCE A SMALL PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A DCDC CODE OF 0 ON BOTH SYSTEMS AND NORMAL MODE. THE PATIENT ALSO REPORTED THAT HE HAD NOT BEEN FEELING STIMULATION. IT WAS SUGGESTED THAT THE OUTPUT CURRENT COULD BE INCREASED TO SEE IF THE PATIENT FELT STIMULATION BUT THE PATIENT WAS ALREADY AT 3.5 MA AND INCREASING THE OUTPUT CURRENT WOULD NOT BE AN OPTION. THE PATIENT WAS SENT FOR X-RAYS AND THE X-RAYS WERE PROVIDED TO THE MANUFACTURER FOR REVIEW. BASED ON THE X-RAYS RECEIVED, NO OBVIOUS ANOMALIES WERE IDENTIFIED THAT COULD BE CONTRIBUTING TO A SHORT CIRCUIT. THERE WERE NO GROSS FRACTURES OR DISCONTINUITIES THAT WERE VISUALIZED. AS THE ENTIRE LEAD COULD NOT BE ASSESSED, CONTINUITY IN THAT PORTION OF THE LEAD CANNOT BE CONFIRMED AND THE POSSIBILITY OF A MICRO-FRACTURE CANNOT BE RULED OUT. REVIEW OF THE PATIENT DIAGNOSTICS IN THE MANUFACTURERS PROGRAMMING HISTORY SHOWED THAT THE PATIENT HAS ALWAYS HAD DCDC CODE OF 0 ON SYSTEM DIAGNOSTICS. THE PHYSICIAN'S OFFICE WAS CONCERNED THAT THERE MAY BE A LEAD BREAK SO THE PATIENT WAS REFERRED FOR A LEAD AND GENERATOR REPLACEMENT. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. THERE WAS NO REPORTED TRAUMA OR MANIPULATION. THE DCDC CODE OF 0 IS THE REASON THAT THE OFFICE FELT THERE MAY BE A LEAD BREAK. THEY UNDERSTAND BASED ON THE PATIENTS HISTORY THAT DCDC CODE OF 0 MAY NOT BE A LEAD BREAK BUT THEY WANTED TO REPLACE THE PATIENT JUST TO BE SURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR AND LEAD REPLACEMENT. PRIOR TO SURGERY DIAGNOSTICS RUN. THE GENERATOR WAS REPLACED FIRST AND DIAGNOSTICS WERE RUN WITH THE NEW GENERATOR BOTH OUTSIDE AND INSIDE THE POCKET. WHEN DIAGNOSTICS WERE RUN INSIDE THE POCKET LOW IMPEDANCE WAS RECEIVED. IT WAS DECIDED TO REPLACE THE LEAD. WHEN DIAGNOSTICS WERE RUN AGAIN THEY WERE WITHIN NORMAL LIMITS. THE GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1022

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR