BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1840050 · Received September 15, 2010

    Report

    Report Number
    1644487-2010-02088
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A <6 MONTHS UNTIL EOS WARNING MESSAGE WAS RECEIVED UPON INITIAL INTERROGATION OF A GENERATOR IN THE STERILE PACKAGE IN THE OPERATING ROOM. THE WARNING MESSAGE WAS NOT RECEIVED ON SUBSEQUENT INTERROGATIONS AND DIAGNOSTIC TESTS. A BACK-UP COPY OF THE FLASHCARD WAS RETURNED (ORIGINAL FLASHCARD WAS NOT RETURNED) BY A COMPANY REP AND THE ALLEGED EVENT WAS CONFIRMED. ANALYSIS IN THE DECODER SPREADSHEET ON (B)(6) 2010 BY THE MANUFACTURER REVEALED INCORRECT DATA FOR MEMORY ADDRESSES 1038-103F ONLY ON THE INITIAL INTERROGATION PERFORMED ON (B)(6) 2010. THESE ADDRESSES INCLUDE THE TRIM VALUES OF DIAGVBATB AND DIAGVBATM. THESE INCORRECT VALUES LED TO THE CALCULATION OF THE BATTERY VOLTAGE TO BE 2.083 V INSTEAD OF THE INTENDED 3.168 V AND RESULTED IN THE EOS MESSAGE RECEIVED BY THE COMPANY REP. THE OTHER INCORRECT VALUES WERE DIAGMAGNETCONSUMEDM, DIAGZNORMB, DIAGZNORMM, PULSECURRENTB, AND DIAGYEAROFMANUFACTURE. THE DHR FOR THIS DEVICE WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED. THE TRIM VALUES PROGRAMMED AT THE POST BURN TEST WERE IDENTIFIED TO BE THE CORRECT VALUES THAT WERE OBTAINED AT ALL INTERROGATIONS AFTER THE INITIAL INTERROGATION. THE EXACT FAILURE MODE WHICH LED TO THIS EVENT IS UNK. THE GENERATOR WAS NOT IMPLANTED. THE GENERATOR WAS RETURNED TO THE MANUFACTURER AND IS CURRENT UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 715914

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR