BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2221385 · Received August 24, 2011

    Report

    Report Number
    1644487-2011-01970
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 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 (B)(4). 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, ADDITIONAL INFORMATION WAS RECEIVED WHEN THE SURGEON REPORTED ON (B)(6) 2011 THAT THE PATIENT'S VNS WILL BE PROGRAMMED BACK ON DESPITE THE COUGHING AND BRADYCARDIA. THE PATIENT HAD NO PRIOR HISTORY OF CARDIAC EVENTS AND NO FAMILY HISTORY OF CARDIAC EVENTS. THE PATIENT ALSO HAD NO PRE-EXISTING MEDICAL CONDITIONS. THE PATIENT'S HEART RATE DURING THE BRADYCARDIA WAS IN THE 30S. THE EVENT OCCURRED POST-OPERATIVE AND THERE WERE NO SYMPTOMS SUGGESTING AN ARRHYTHMIA, NO TRAUMATIC EVENTS PRIOR TO THE ARRHYTHMIA, NO TRIGGERS, AND THE EVENT DID NOT OCCUR FOLLOWING A MEDICATION. THE SURGEON REPORTED THAT THE ARRHYTHMIA CORRELATED WITH THE ON TIME OF THE VNS FOLLOWING A SETTING CHANGE. THE EVENT DID NOT OCCUR WHILE PERFORMING DIAGNOSTICS. AN ECG WAS PERFORMED TO DIAGNOSE THE ARRHYTHMIA. THE SURGEON REPORTED THAT HE BELIEVES THE ARRHYTHMIA WAS RELATED TO VNS STIMULATION. THE SURGEON STATED THAT WHEN HE REVISED THE PATIENT'S LEAD AND ATTACHED THE LEAD TO THE GENERATOR, IT WAS DISCOVERED THAT THE GENERATOR HAD NEVER BEEN DISABLED AND WAS STILL ON. BECAUSE OF THE ARRHYTHMIA HE DISABLED THE VNS TO PRECLUDE A SERIOUS INJURY. THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THE ARRHYTHMIA. ALTHOUGH THE GENERATOR IS NOT CURRENTLY PROGRAMMED ON, THE SURGEON STATED THAT IT WILL BE PROGRAMMED BACK ON IN THE FUTURE. THE ARRHYTHMIA EVENT HAS NOT RECURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS IMPLANTING SURGEON REPORTED THAT THE VNS PATIENT HAD LEAD REPLACEMENT SURGERY THAT DAY DUE TO HIGH LEAD IMPEDANCE (HIGH IMPEDANCE REPORTED ON MANUFACTURER REPORT NUMBER 1644487-2011-01486). THE PATIENT EXPERIENCED POSTOPERATIVE BRADYCARDIA AND COUGHING. THE SURGEON REPORTED THAT IT WAS DUE TO THE FACT THAT THE PATIENT HAD NOT BEEN RECEIVING STIMULATION BECAUSE OF THE HIGH IMPEDANCE AND THEREFORE WAS NOT USED TO THE STIMULATION AFTER THE NEW LEAD WAS ATTACHED. DURING SURGERY, IT WAS DISCOVERED THAT THE PATIENT HAD NEVER BEEN PROGRAMMED TO 0MA DESPITE THE HIGH IMPEDANCE AND THE PATIENT WAS LEFT PROGRAMMED TO OUTPUT=2.25MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=0.8MIN/MAGNET OUTPUT=2.5MA/MAGNET PULSE WIDTH=250USEC/MAGNET ON TIME=60SEC. THE PATIENT WAS THEN PROGRAMMED OFF AND THE BRADYCARDIA RESOLVED. SYSTEM DIAGNOSTICS AFTER SURGERY SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=2400OHMS. IT WAS REPORTED THAT THE PATIENT WILL FOLLOW UP WITH THE NEUROLOGIST THE FOLLOWING WEEK TO BE TURNED BACK ON. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN TO NO AVAIL THUS FAR. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2709

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention