BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2102394 · Received May 20, 2011

    Report

    Report Number
    1644487-2011-01057
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    November 21, 2007
    Report Date
    April 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE PT'S VNS GENERATOR "INTENSIFIED F/U INDICATOR (IFI)" HAD TRIPPED EARLIER THAN EXPECTED. BASED ON THE PT'S SETTINGS AND THE BATTERY LIFE ESTIMATION TABLES IN THE PHYSICIAN'S MANUAL, THE VNS GENERATOR IFI INDICATOR LIKELY SHOULD NOT HAVE TRIPPED. 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 THE PREVIOUS PROGRAMMING HISTORY IDENTIFIED THAT THE VOLTAGE MEASURED BY THE GENERATOR LESS THAN ONE YEAR AFTER IMPLANT (2.756V) WAS UNCHARACTERISTICALLY LOW BASED ON PT 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 APPROX 2 YEARS, WHICH IS UNEXPECTED BEHAVIOR AT THESE VOLTAGES. A REVIEW OF THE GENERATOR'S DEVICE HISTORY RECORD (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 THE SPEC, WHICH APPEARS TO EXPLAIN THE LOWER MEASURED VOLTAGE VALUE. ATTEMPTS FOR ADDITIONAL INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS, INC. 104 1952

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female