BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3050602 · Received April 10, 2013

    Report

    Report Number
    1644487-2013-00976
    Event Type
    Death
    Date Received
    April 10, 2013
    Date of Event
    November 11, 2012
    Report Date
    March 11, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THIS PATIENT WAS DECEASED. FOLLOW-UP SHOWED THAT THE PATIENT HAD NOT BEEN SEEN SINCE 2007 AND RECORDS WERE UNAVAILABLE. FOLLOW-UP WITH THE FUNERAL HOME SHOWED THAT THE DEVICE WAS NOT EXPLANTED. THE MANNER OF DEATH WAS NATURAL CAUSES. THE CAUSE OF DEATH WAS A COMPLICATION OF ALZHEIMER'S TYPE DEMENTIA FOR A DURATION OF 5 YEARS. AN IN-HOUSE SUDEP EVALUATION DETERMINED THE DEATH TO BE NOT SUDEP. REVIEW OF PROGRAMMING HISTORY SHOWS THAT THE PATIENT'S DEVICE WAS PROGRAMMED OFF (B)(6) 2007 DUE TO HIGH IMPEDANCE THAT WAS REPORTED IN MFR REPORT # 1644487-2007-01559.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152664 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 5919

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death