BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3080814 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01160
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    October 2, 2012
    Report Date
    April 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR WAS COMPLETED ON (B)(4) 2013. RESULTS OF DIAGNOSTIC TESTING AND MONITORING INDICATED THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=NO IN THE PA LAB. THE BATTERY IS NOT DEPLETED, 2.946 VOLTS (NOT AT IFI) AS MEASURED DURING COMPLETION OF THE FINAL ELECTRICAL TEST. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT THE PATIENT'S GENERATOR WAS DEPLETING QUICKER THAN EXPECTED WITH 1/3 GREEN REMAINING ON THE VISUAL IFI INDICATOR. THE PATIENT'S GENERATOR HAD BEEN IMPLANTED IN FEBRUARY 2012. THE PHYSICIAN PROJECTED ABOUT 6 MONTHS REMAINING ON THE 2/3RDS DEPLETED BATTERY. HER CURRENT SETTINGS AT THE TIME WERE: OUTPUT = 2.75 MA/ FREQUENCY = 20 HZ/ PULSE WIDTH = 250 MICROSECONDS / ON- TIME = 7SECONDS/OFF-TIME = 0.3 MINUTES/MAGNET OUTPUT=3MA/MAGNET PULSE WIDTH=250USEC/MAGNET ON TIME=60SEC. THE PHYSICIAN EXPRESSED DISSATISFACTION WITH THE AMOUNT OF BATTERY LIFE FOR GENERATORS IF THE PATIENTS ARE ON RAPID CYCLING. HE STATED THAT HAVING A BATTERY LIFE TOTAL OF LESS THAN A YEAR IS VERY POOR. PREVIOUSLY, ON (B)(6) 2012 IT WAS REPORTED THAT THE VNS PATIENT'S BATTERY INDICATOR WAS SHOWING 4/5TH GREEN. THE PATIENT WAS NOTED TO BE ON RAPID CYCLE OF 7 SEC ON, 0.3 MIN OFF, 2.75 OUTPUT, AND 3.0 MAGNET. THE BATTERY LONGEVITY TABLES WERE REVIEWED. A WORST-CASE SCENARIO OF: OUTPUT = 3MA/FREQUENCY = 30/ PULSE WIDTH = 500 WITH A 50% DUTY CYCLE ESTIMATES BEGINNING OF LIFE TO IFI: 0.7 YEARS. THE PATIENT WAS NOT YET AT IFI=YES (4/5=80% BATTERY LIFE LEFT). THE MANUFACTURING RECORDS FOR THE GENERATOR WERE REVIEWED AND DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO BATTERY DEPLETION. THE GENERATOR WAS RECEIVED BY THE DEVICE MANUFACTURER ON (B)(6) 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180830 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3151

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR