BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4961837 · Received August 3, 2015

    Report

    Report Number
    1644487-2015-05412
    Event Type
    Death
    Date Received
    August 3, 2015
    Date of Event
    November 21, 2011
    Report Date
    July 10, 2015
    Manufacturer
    CYBERONICS INC
    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

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    THE DEATH OF A PATIENT WAS REPORTED ON (B)(6) 2015. THE PATIENT WAS REPORTED TO HAVE DIED ON (B)(6) 2011 DUE TO UNKNOWN REASONS. THE "PATIENT'S" OBITUARY WAS FOUND, WHICH CONFIRMED THE DEATH DATE TO BE (B)(6) 2011. THE PATIENT WAS CREMATED, AND THE DEVICE WAS EXPLANTED PRIOR TO CREMATION. THE DEVICE WAS NOT AVAILABLE FOR RETURN. THE CAUSE OF DEATH WAS OF UNDETERMINED NATURAL CAUSES. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN MADE BUT NO RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503854 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 11003

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death