BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 100

    MDR report key: 4243851 · Received November 11, 2014

    Report

    Report Number
    1644487-2014-02988
    Event Type
    Death
    Date Received
    November 11, 2014
    Date of Event
    February 18, 2012
    Report Date
    October 15, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE (MO/DAY/YR), CORRECTED DATA: THE INITIAL REPORT INDICATED THE GENERATOR WAS EXPLANTED IN 2012 HOWEVER, THE DEVICE WAS ACTUALLY EXPLANTED IN 2008. THE INFORMATION HAS BEEN CORRECTED IN THIS REPORT.

    Description of Event or Problem · 1

    AN EXPLANTED GENERATOR WAS RECEIVED FOR ANALYSIS. IT WAS UNKNOWN WHY THE GENERATOR HAD BEEN EXPLANTED. AN ONLINE SEARCH OF THE PATIENT'S NAME IDENTIFIED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2014. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. THEREFORE, THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PA LAB, WILL BE USED TO CONCLUDE THAT NO ANOMALIES EXISTED. THE BATTERY WAS DEPLETED AS EXPECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE PATIENT¿S GENERATOR WAS EXPLANTED PRIOR TO THE PATIENTS. DEATH OCCURRED ON (B)(6) 2012 AND THE PATIENT¿S GENERATOR WAS EXPLANTED FOUR YEARS PRIOR ON (B)(6) 2008. ADDITIONALLY, IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED OFF SINCE 1992. THE REASON FOR EXPLANT WAS UNKNOWN AND THE PATIENT WAS NOT RE-IMPLANTED WITH A NEW GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725854 PULSE GEN MODEL 100 GENERATOR LYJ CYBERONICS, INC. 100 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death