BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2201312 · Received August 3, 2011

    Report

    Report Number
    1644487-2011-01767
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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

    METHOD: ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN REPORTED THAT HE SAW THE VNS PT ON (B)(6) 2011 AND THE PT WAS COMPLAINING OF PAINFUL STIMULATION IN THE CHEST AREA, ABOVE THE CLAVICLE. THE PHYSICIAN DID EVOKED POTENTIAL MONITORING AND NOTICED A BREAK DOWN OF SKIN WHERE THE PT WAS COMPLAINING OF PAIN. IT APPEARED THAT STIMULATION WAS STOPPING AT THE CLAVICLE WHERE THE SKIN WAS BREAKING DOWN. THE PHYSICIAN HAD THREE SETS OF X-RAY TAKEN AND FLUOROSCOPY PERFORMED ALL OF WHICH WILL NOT BE SENT TO THE MFR FOR REVIEW. THE PHYSICIAN REPORTED THAT THE X-RAY DID NOT SHOW ANY LEAD BREAKS. THE PT'S DEVICE WAS DISABLED AND THE PAINFUL STIMULATION RESOLVED. THE PT WAS THEN SCHEDULED FOR A FULL REVISION SURGERY. THE PT IS A SWIMMER AND DOES DO BUTTERFLY STROKE, BUT NO TRAUMA OR MANIPULATION WAS REPORTED. THE PHYSICIAN BELIEVES THAT THE LEAD IS FRAYED AND DID NOT WANT TO PERFORM ANY DIAGNOSTICS BECAUSE THE PT WAS IN PAIN. THE CONSULTANT REQUESTED THAT DIAGNOSTICS THEN BE PERFORMED PRIOR TO SURGERY WHEN THE PT IS UNDER ANESTHESIA. THE CONSULTANT WAS UNABLE TO ATTEND THE PT'S FULL REVISION SURGERY ON (B)(6) 2011; THEREFORE, THE OPERATING ROOM CIRCULATING NURSE REPORTED THAT SHE WOULD HAVE EITHER THE NEURO-TECH WHO NORMALLY DOES THE VNS PROGRAMMING IN THE OPERATING ROOM TO CALL THE CONSULTANT ONCE THE SYSTEM AND NORMAL MODE DIAGNOSTICS WERE RUN PRIOR TO THE PT'S REVISION SURGERY. THE CONSULTANT NEVER RECEIVED A CALL SO IT WAS UNK AT THIS TIME WHETHER DIAGNOSTICS WERE INDEED PERFORMED. THE CONSULTANT IS SCHEDULED TO MEET WITH THE SURGEON AT A LATER DATE. THE LEAD IMPEDANCE WAS REPORTED TO BE OK AFTER THE SURGERY. THE EXPLANTED PRODUCT WAS RETURNED FOR PRODUCT ANALYSIS ON (B)(6) 2011, WHICH HAS NOT YET BEEN COMPLETED. THE PT'S PROGRAMMING HISTORY WAS REVIEWED WHICH REVEALED THAT THE PT'S LAST SYSTEM DIAGNOSTIC TEST WAS PERFORMED ON NOVEMBER 10, 2010 WHICH SHOWED OUTPUT = OK/LEAD IMPEDANCE = OK/DCDC = 1/ERI = NO. THE PT'S SETTINGS ON (B)(6) 2010 WERE OUTPUT - 2MA/FREQUENCY = 20 HZ/PULSE WIDTH = 250 USEC/ON TIME - 21 SEC/OFF TIME = 3 MIN/MAGNET OUTPUT = 2.75 MA/MAGNET PULSE WIDTH = 250 USEC/MAGNET ON TIME = 60 SEC. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE PROGRAMMING HISTORY AVAILABLE WHICH REVEALED 6.91 YEARS UNTIL ERI = YES. WHEN ADD'L INFO IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN THE PHYSICIAN REPORTED THAT THE PATIENT HAS BEEN DOING WELL WITH NO PAINFUL STIMULATION SINCE REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011, WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED LEAD. THE GREEN NEGATIVE ELECTRODE, A PORTION OF THE WHITE POSITIVE AND GREEN NEGATIVE ELECTRODE QUADFILAR COILS, AND A PORTION OF THE ANCHOR TETHER HELICAL WERE NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS OF THE RETURNED 8 MM PORTION THE END OF THE WHITE POSITIVE ELECTRODE QUADFILAR COIL APPEARED TO BE MELTED. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND THE AREA WAS IDENTIFIED AS HAVING THE APPEARANCE OF BEING MELTED, WITH RE-SOLIDIFIED MATERIAL. IT IS UNKNOWN EXACTLY WHAT CAUSED THE QUADFILAR COIL TO MELT. BASED ON THE OBVIOUS SIGNS OF MECHANICAL DAMAGE ON THE COIL SURFACE, IT IS POSSIBLE THE THERMALLY-DAMAGED COIL WAS EXPOSED TO A HIGH TEMPERATURE DEVICE SUCH AS A CAUTERIZING TOOL DURING THE EXPLANT OF THIS LEAD. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PINS PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST A DISCONTINUITY IN THE RETURNED PORTION OF THE DEVICE; HOWEVER SINCE PORTIONS OF THE LEAD WERE NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. WHAT APPEARED TO BE REMNANTS OF DRIED BODY FLUIDS WERE OBSERVED INSIDE THE INNER SILICONE TUBES, IN SOME AREAS. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THERE WAS NO OBVIOUS PATH FOR FLUID INGRESS. PUNCTURE MARKS WERE OBSERVED ON THE INNER SILICONE TUBES, PAST THE ELECTRODE BIFURCATION. THE MARKS PENETRATED THE INSULATION AND THE QUADFILAR COILS APPEARED TO BE KINKED. TOOL MARKS WERE OBSERVED ON THE MARKED CONNECTOR INNER SILICONE TUBING. THE MARKS PENETRATED THE INSULATION AND THREE OF THE MARKED QUADFILAR COIL STRANDS APPEARED TO HAVE BEEN CUT IN HALF. THE GOUGE AND PUNCTURE MARKS APPEARED TO HAVE BEEN MADE BY A SHARP OBJECT WHICH COULD HAVE OCCURRED DURING THE EXPLANT PROCEDURE, HOWEVER THIS CANNOT BE CONFIRMED. THE TORN APPEARANCE OF THE ELECTRODE BIFURCATION AND KINKED QUADFILAR COIL MOST LIKELY OCCURRED DUE TO MANIPULATION OF THE LEAD DURING THE EXPLANT PROCEDURE. PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR WAS COMPLETED ON (B)(4) 2011. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND NO ERI FLAGS WERE OBSERVED DURING TESTING. THE DEVICE WAS CONTINUOUSLY MONITORED FOR 26.5 HOURS. THE PROGRAMMED OUTPUT CURRENT MEASURED WITHIN LIMITS AND SHOWED NO SIGNS OF VARIATION. DIAGNOSTIC VALUES WERE AS EXPECTED FOR THE PROGRAMMED SETTINGS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. THE CONSULTANT REPORTED THAT HE WOULD MEET WITH THE PHYSICIAN IN SEPTEMBER 2011 AND WOULD FIND OUT HOW THE PATIENT IS DOING SINCE THE FULL REVISION SURGERY. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    THE PATIENT'S FATHER WROTE A BOOK DESCRIBING THE PATIENT'S EPILEPSY. THE BOOK DESCRIBED THE PAINFUL STIMULATION THAT OCCURRED IN (B)(6) 2011. THE BOOK REPORTED THE ELECTRICAL CHARGE WAS LEAVING THE STIMULATOR PROPERLY. IT WAS STOPPING RIGHT WHERE [THE PATIENT] WAS FEELING THE SHOCK. THERE WAS ALSO A DESCRIPTION OF A RED MARK ON THE SHOULDER, NEAR WHERE THE PAINFUL STIMULATION WAS OCCURRING. THE RED MARK ON HIS SHOULDER WAS DESCRIBED AS DIRECTLY OVER THE PATH OF THE WIRE THAT WAS HOOKED UP TO HIS STIMULATOR. THE PATIENT'S PHYSICIAN REPORTEDLY TURNED THE DEVICE OFF DUE TO THE PAINFUL STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-30 32039C

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR