BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3222662 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02079
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. NO ANOMALIES WERE NOTED IN THE MANUFACTURER'S REVIEW OF THE PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013 INFORMATION WAS RECEIVED FROM THE REPORTER THAT DURING INTERROGATION OF THE PATIENT¿S GENERATOR ON THAT DAY THE OBSERVED RESULTS STATED THAT THE GENERATOR WAS TURNED OFF AND WAS NEAR END OF SERVICE, DESPITE IMPLANTATION LESS THAN TWO YEARS PRIOR. FOLLOW-UP WITH ANOTHER INTERROGATION ON (B)(6) 2013 SHOWED NO INDICATION OF BATTERY DEPLETION AND SYSTEM AND NORMAL MODE DIAGNOSTICS CHECKED OUT NORMAL; THUS NO CHANGES WERE MADE TO THE PATIENT¿S GENERATOR PARAMETERS. A REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY WAS PERFORMED, SHOWING THAT PROGRAMMING HISTORY DATA IS AVAILABLE FROM (B)(6) 2011 TO (B)(6) 2012. THERE WERE NO NOTED PROGRAMMING OR DIAGNOSTICS ANOMALIES. ATTEMPTS FOR ADDITIONAL INFORMATION WILL REMAIN IN CONTINUATION.

    Description of Event or Problem · 1

    ADDITIONAL PROGRAMMING HISTORY WAS RECEIVED ON (B)(4) 2013. ON (B)(6) 2013 THE GENERATOR WAS INITIALLY INTERROGATED, IN WHICH IT WAS DETERMINED THAT THE GENERATOR WAS PULSE DISABLED AND THERE WAS HIGH IMPEDANCE. THE GENERATOR THEN EXPERIENCED A FAULTED SYSTEMS DIAGNOSTICS SEVERAL MINUTES LATER, RESULTING IN AN INDICATION THAT THE GENERATOR WAS NEAR END OF SERVICE, IN ADDITION TO THE GENERATOR REMAINING PULSE DISABLED AND AT HIGH IMPEDANCE. A SUCCESSFUL SYSTEMS DIAGNOSTICS WAS PERFORMED IMMEDIATELY AFTER THE FAULTED DIAGNOSTICS, WHICH RESULTED IN A STATUS THAT THE GENERATOR WAS NOT NEAR END OF SERVICE AND THAT THERE WAS LOW OUTPUT CURRENT BEING DELIVERED. THE GENERATOR WAS NO LONGER PULSE DISABLED AND IMPEDANCE WAS NORMAL. THE EVENT WAS RESOLVED ON (B)(6) 2013 AS WAS REPORTED IN MFR. REPORT 1644487-2013-02079 VERSION #0. IT WAS DETERMINED THAT THIS EVENT WAS THE RESULT OF A COMPUTER OPERATING SYSTEM ISSUE IN THE GENERATOR DUE TO FLASH MEMORY CORRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323370 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2897

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR