BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2224124 · Received August 26, 2011

    Report

    Report Number
    1644487-2011-01999
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, CYBERONICS, OR CYBERONICS'; EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR "MALFUNCTIONS". THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND CYBERONICS OBJECTS TO THEIR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS IMPLANTING SURGEON REPORTED THAT DURING THE VNS PATIENT'S INITIAL SURGERY WHEN HE DISSECTED DOWN TO THE NERVE, THE PATIENT EXPERIENCED BRADYCARDIA AND WENT INTO ASYSTOLE FOR APPROXIMATELY 5 SECONDS. NO PORTION OF THE VNS SYSTEM WAS IMPLANTED AT THAT TIME. AS THE HOSPITAL STAFF WAS ABOUT TO PERFORM CPR, THE PATIENT'S HEART RATE BEGAN RISING AND REACHED A LEVEL THEY WERE COMFORTABLE WITH. THE PATIENT DOES NOT HAVE A HISTORY OF HEART CONDITIONS. AFTER THIS, MEDICINE WAS ADMINISTERED TO THE PATIENT. THE SURGEON REPORTED THAT THIS CARDIAC EVENT WAS DUE TO THE MANIPULATION OF THE VAGUS NERVE. THE SURGEON PERFORMED TWO SYSTEM DIAGNOSTIC TESTS AND THE HEART RATE REMAINED NORMAL. THE SURGEON WAS WORRIED THAT THE HEART RATE WAS ONLY STABLE DUE TO THE FACT THAT THE PATIENT WAS ON MEDICATION. HE DECIDED TO WAIT FOR THE MEDICATION TO WEAR OFF AND THEN PROGRAM THE PATIENT ON TO AN OUTPUT OF 0.25MA IN THE RECOVERY ROOM TO SEE HOW THE PATIENT RESPONSES TO THE OUTPUT CURRENT ON AND THEN HE WOULD PROGRAM THE PATIENT BACK OFF. WHEN THE PATIENT WAS PROGRAMMED TO 0.25MA LATER ON, THE PATIENT RESPONDED FINE WITH NO CARDIAC EVENTS. GOOD FAITH ATTEMPTS FOR PRODUCT INFORMATION FROM THE IMPLANTING HOSPITAL ARE UNDERWAY BUT NO INFORMATION HAS BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011 WHEN THE OPERATIVE REPORT WAS RECEIVED FROM THE SURGEON. DURING SURGERY THE VAGUS NERVE, JUGULAR VEIN, AND CAROTID ARTERY WERE EXPOSED AND IDENTIFIED. THE SURGEON REPORTED THAT THE VAGUS NERVE WAS ENLARGED AND DYSMORPHIC WITH BULBOUS ASPECTS. THE SURGEON STATED THAT THIS WAS HIGHLY ATYPICAL AND WAS FELT TO BE RELATED TO THE PATIENT'S UNDERLYING DIAGNOSIS OF NEUROFIBROMATOSIS. DURING THE EXPOSURE OF THE VAGUS NERVE, THE NERVE WAS AT ONE POINT IRRIGATED WITH COLD SALINE AND THE PATIENT BECAME ASYSTOLIC FOR ABOUT 5 SECONDS. THIS IMPROVED SPONTANEOUSLY, ALTHOUGH THE PATIENT WAS ALSO GIVEN TREATMENT BY THE ANESTHESIA TEAM WITH AN ANTICHOLINERGIC AGENT ROBINUL. THE PATIENT SPONTANEOUSLY IMPROVED AND VITAL SIGNS REMAINED STABLE THROUGHOUT THE REMAINING CASE. ALL ADDITIONAL IRRIGATION WAS CARRIED OUT WITH WARM SALINE. AT THE END OF SURGERY, THE VNS WAS TURNED ON TO OUTPUT=0.25MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=5MIN. THERE WAS NO CHANGE IN THE HEART RATE OF APPROXIMATELY 70-80 BEATS PER MINUTE WITH THE VNS PROGRAMMED ON. ULTIMATELY THE PATIENT WAS EXTUBATED WITHOUT COMPLICATION AND ROLLED INTO THE POSTOPERATIVE RECOVERY AREA IN STABLE NEUROLOGICAL CONDITION. BECAUSE OF THE PATIENT'S BRIEF PERIOD OF ASYSTOLE, THE SURGEON REPORTED THAT THE PATIENT WILL BE ADMITTED TO THE HOSPITAL FOR CLOSE MONITORING WITH TELEMETRY. IT WAS LATER REPORTED THAT DURING THE PATIENT'S POST OPERATION OBSERVATION, THE OVERNIGHT TELEMETRY WAS NEGATIVE FOR ANY CARDIAC EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention