BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1820074 · Received August 24, 2010

    Report

    Report Number
    1644487-2010-01931
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS DEIMPULSE GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS, MEDWATCH REPORT NUMBER: 1644487-2010-01776. IT WAS REPORTED THAT THE PATIENT HAD THEIR VNS EXPLANTED DUE TO BEING SEIZURE FREE. IT WAS NOT REPLACED. AN END OF BATTERY CONDITION WAS DUPLICATED IN THE PRODUCT ANALYSIS LABORATORY. HOWEVER, WHILE DIAGNOSTIC TESTING RESULTS INDICATED THE ESTIMATED TIME TO EOS WAS 2 MONTH (AT THE SETTINGS OBTAINED FROM THE PROGRAMMING HISTORY DATABASE), DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT ONLY 52.036% OF THE BATTERY HAD BEEN CONSUMED (WITH A BATTERY VOLTAGE OF 2.453 VOLTS). THE OBSERVED LOW BATTERY VOLTAGE IS DUE TO AN INCREASED CURRENT DRAIN CONSUMPTION WHEN THE DEVICE IS PROGRAMMED TO CONDITIONS WHEREBY COMPLIANCE VOLTAGES GREATER THAN 10.5V ARE REQUIRED. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS, EXCEPT FOR A MEASURED BATTERY VOLTAGE OF 2.528 VOLTS WHICH IS BELOW THE MINIMUM PER SPECIFICATIONS OF 2.6 VOLTS. THIS IS AN EXPECTED EVENT SINCE THE BATTERY IS PARTIALLY DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200604

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR