BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2043128 · Received March 25, 2011

    Report

    Report Number
    1644487-2011-00635
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 23, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INITIAL INTERROGATION OF A PATIENT'S M103 GENERATOR, FOLLOWING THE 8.0 UPGRADE PROCESS, RESULTED IN AN UNEXPECTED "INTENSIFIED FOLLOW-UP INDICATOR (IFI)=YES" NOTIFICATION WHICH IS TRIGGERED AT GENERATOR VOLTAGES BELOW 2.8V. THE ALERT IS MEANT TO SERVE AS A NOTIFICATION TO THE TREATING PHYSICIAN THAT MORE FREQUENT CLINICAL MONITORING IS RECOMMENDED AS THE GENERATOR BATTERY WAS MEASURED TO BE AT A LEVEL WHERE MORE FREQUENT CLINICAL MONITORING IS RECOMMENDED. A REVIEW OF PAST PROGRAMMING HISTORY IDENTIFIED THAT THE VOLTAGE MEASURED BY THE GENERATOR 10 MONTHS AFTER IMPLANT (2.779V) WAS UNCHARACTERISTICALLY LOW BASED ON PATIENT THERAPY SETTINGS, SYSTEM IMPEDANCE AND IMPLANT DURATION. ADDITIONALLY, BASED ON THE TIMING OF THE INITIAL REPORT, IT APPEARS THAT THE MEASURED GENERATOR VOLTAGE HAS BEEN WITHIN THE IFI LIMITS (WHICH CORRESPONDS TO THE LAST 25% OF REMAINING BATTERY CAPACITY) FOR APPROXIMATELY 2 YEARS, WHICH IS UNEXPECTED BEHAVIOR AT THESE VOLTAGES. A REVIEW OF THE DEVICE'S DHR REVEALED THAT ALL ELECTRICAL TESTS/VISUAL INSPECTIONS WERE PASSED PRIOR TO DEVICE SHIPMENT AND THAT THE VOLTAGE MEASUREMENT ACCURACY OF THE GENERATOR WAS NEAR THE LOWER LIMIT OF SPECIFICATION, WHICH APPEARS TO EXPLAIN THE LOWER MEASURED VOLTAGE VALUE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION ARE CURRENTLY IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200616

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female