BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 6176795 · Received December 15, 2016

    Report

    Report Number
    1644487-2016-02869
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    March 3, 2013
    Report Date
    November 18, 2016
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2013. THE DEATH WAS IDENTIFIED THROUGH AN OBITUARY SEARCH AS THE PATIENT'S DEVICE WAS SUSPECTED TO BE AT END-OF-SERVICE BASED ON BATTERY LIFE EXPECTANCY. THE PATIENT'S DEVICE WAS KNOWN TO HAVE BEEN PROGRAMMED OFF IN 2011. PROGRAMMING HISTORY WAS AVAILABLE UP TO 2005, AND HIGH IMPEDANCE WAS PRESENT IN THE PATIENT'S DEVICE (REPORTED IN MFR. REPORT #1644487-2008-02590). ATTEMPTS TO THE TREATING PHYSICIAN WERE UNSUCCESSFUL, SO IT IS UNKNOWN IF THE PATIENT'S DEVICE WAS PROGRAMMED BACK ON PRIOR TO THE PATIENT'S DEATH. IT WAS REPORTED BY THE FUNERAL HOME ATTENDANT THAT THE DEATH WAS THOUGHT TO HAVE BEEN DUE TO A FALL THAT LEAD TO COMPLICATIONS, ULTIMATELY CAUSING DEATH. HOWEVER, THE OFFICIAL CAUSE OF DEATH WAS NOT AVAILABLE. THE PATIENT'S DEVICE WAS NOT EXPLANTED. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829508 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS - HOUSTON 101 5985

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death