BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2800387 · Received October 22, 2012

    Report

    Report Number
    1644487-2012-02673
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    February 23, 2009
    Report Date
    September 28, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF THE DEVICES DEVICE HISTORY RECORDS REVEALED ALL LINE ITEMS PASSED MANUFACTURING AND QUALITY CONTROL INSPECTION STEPS AND ALL ELECTRICAL TESTS PASSED WITH NO ANOMALIES NOTED.

    Description of Event or Problem · 1

    A REVIEW OF THE DEVICE PROGRAMMING HISTORY AND THE GENERATOR SOURCE CODE BY THE MANUFACTURER INDICATES THAT THE DEVICE MAY HAVE PREMATURELY DEPLETED. REVIEW OF THE DATA REVEALS THAT THE PERCENTAGE OF BATTERY CONSUMED WAS LOWER THAN EXPECTED GIVEN THE VBAT MEASUREMENTS AT FOLLOW UP VISITS THAT OCCURRED ON (B)(6) 2009. THERE DO NOT APPEAR TO BE ANY SYSTEM LIMITATIONS (IE, NORMAL IMPEDANCE OF (B)(4), THE DEVICE IS ABLE TO DELIVER THE PROGRAMMED OUTPUT CURRENT OF (B)(4)) THAT COULD BE CONTRIBUTING TO THE DISCREPANCY. THE DEVICE WAS PROGRAMMED TO 2.5 MA/20 HZ/500 USEC/30 SEC/0.8 MIN (AT A 44% DUTY CYCLE) ON (B)(6) 2008, WHICH WAS TWO MONTHS AFTER THE IMPLANT DATE OF THE DEVICE. AN ESTIMATE OF BATTERY LIFE UTILIZING THESE SETTINGS SUGGESTS THAT THE DEVICE SHOULD HAVE LASTED SOMEWHERE BETWEEN 2-3.1 YEARS. THOUGH THIS SETTING WAS LATER CHANGED TO 2.75 MA/20 HZ/250 USEC/30 SEC/1.1 MIN ON (B)(6) 2009, THE ROUGH ESTIMATION FOR WORST CASE BATTERY LONGEVITY IS STILL LONGER THAN THE ACTUAL LONGEVITY (APPROX 1.2 YEARS). GIVEN THAT THE DEVICE WAS IMPLANTED FOR (B)(6) AT WHICH TIME THE BATTERY WAS DEPLETED, IT APPEARS THAT THE DEVICE REACHED END OF SERVICE PREMATURELY DUE TO AN UNKNOWN REASON. PREVIOUS FOLLOW UP WITH THE EXPLANTING HOSPITAL REVEALED THAT THE DEVICE WAS DISCARDED FOLLOWING EXPLANT, AND THE DEVICE IS THEREFORE NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. REVIEW OF THE DEVICES DEVICE HISTORY RECORDS REVEALED ALL LINE ITEMS PASSED MANUFACTURING AND QUALITY CONTROL INSPECTION STEPS AND ALL ELECTRICAL TESTS PASSED WITH NO ANOMALIES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS INC 104 016389

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR