BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 2834449 · Received November 15, 2012

    Report

    Report Number
    1644487-2012-03019
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN EPILEPSY PATIENT ((B)(6)) WAS ENROLLED IN THE (B)(6) STUDY. THE (B)(6) STUDY IS AN OBSERVATIONAL, UNBLINDED, MULTI-SITE STUDY DESIGNED TO COLLECT DATA ON PATIENTS WITH MEDICALLY REFRACTORY SEIZURE DISORDERS WHO ARE IMPLANTED WITH THE MODEL 106 VNS THERAPY SYSTEM. THE MODEL 106 IPG IS SIMILAR IN HARDWARE, DIAGNOSTICS, AND SOME ASPECTS OF DEVICE DESIGN TO A COMMERCIALLY APPROVED DEVICE, THE MODEL 105 IPG. AS A PART OF THE IMPLANT PROCEDURE, AN INTRA-OPERATIVE LEAD TEST IS DONE TO VERIFY PROPER FUNCTION AND CONNECTION OF THE SYSTEM. THIS TESTING IS PERFORMED FOR COMMERCIALLY AVAILABLE VNS THERAPY SYSTEMS AND IS NOT UNIQUE TO THE INVESTIGATIONAL PROCEDURE OR PROTOCOL. THE TEST INVOLVES DELIVERING A TRAIN OF VNS STIMULUS OF 1.0 MA AMPLITUDE THROUGH THE LEAD AND TO THE NERVE. DURING THIS TEST, THE PATIENT EXPERIENCED A SERIOUS, SINGLE EPISODE OF ASYSTOLE THAT LASTED 4-5 SECONDS IN DURATION. THIS EVENT WAS SELF-TERMINATING AND WAS CONSIDERED RESOLVED ON (B)(6) 2012. THERE WAS NO ACTION TAKEN IN RESPONSE TO THE EVENT. IN THE OPINION OF THE INVESTIGATOR, THE EVENT OF CARDIAC ASYSTOLE WAS NOT RELATED TO THE IMPLANTATION AND WAS PROBABLY RELATED TO THE STIMULATION OF THE DEVICE AS THE EVENT OCCURRED DURING THE INTRA OPERATIVE SYSTEM TEST. THIS IS A RARE, BUT EXPECTED EVENT THAT IS IDENTIFIED IN BOTH THE INVESTIGATOR'S BROCHURE AND THE DEVICE LABELING. THE VNS DEVICE IS FUNCTIONING PROPERLY, AND THE PATIENT WILL CONTINUE PARTICIPATION IN THE CLINICAL TRIAL.

    Description of Event or Problem · 1

    THE FOLLOW-UP REPORT RECEIVED ON (B)(6) 2012, PROVIDED THE FOLLOWING INFORMATION: THE INVESTIGATOR CONFIRMED THE PATIENT DID NOT HAVE A MEDICAL HISTORY PRIOR TO THE EVENT OF CARDIAC ASYSTOLE, AND THE INVESTIGATOR CONFIRMED THE PATIENT DID NOT HAVE A FAMILY HISTORY OF CARDIAC EVENTS. THE PATIENT DOES NOT HAVE ANY ABNORMAL VAGAL ANATOMY. THE PATIENT'S HEART RATE PRIOR TO THE EVENT WAS 65 BPM, BLOOD PRESSURE WAS 100/50 MMHG, AND AFTER THE EVENT WAS 145/75 MMHG. SINCE THE ONSET OF THE EVENT OF CARDIAC ASYSTOLE, THE DEVICE HAS BEEN PROGRAMMED ON WITH THE FOLLOWING SETTINGS: OUTPUT CURRENT = 0.75MA, SIGNAL FREQUENCY = 20HZ, PULSEWIDTH = 500 MICROSECONDS, AUTO-STIM CURRENT= 0.75MA, SEIZURE DETECTION = ON, SDA = 6, BLACKOUT TIME = 30 SECONDS, AND HEARTBEAT SENSITIVITY = 3. THE INVESTIGATOR CONFIRMED NO FURTHER ARRHYTHMIA EVENTS HAVE OCCURRED SINCE THE EVENT OF CARDIAC ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS INC 106 202200

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other