BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3912720 · Received July 3, 2014

    Report

    Report Number
    1644487-2014-01689
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    February 9, 2011
    Report Date
    June 4, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING AND DIAGNOSTIC HISTORY, IT WAS OBSERVED THAT A FLASH MEMORY READ ERROR OCCURRED ON (B)(6) 2011 THAT CAUSED AN INCORRECT CALCULATION OF THE END OF SERVICE (EOS) PROJECTION. THE ISSUE DID NOT REOCCUR AND SUBSEQUENT INTERROGATIONS ON (B)(6) 2011 SHOWED CORRECT EOS PROJECTIONS. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390269 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 1942

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR