BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 4737791 · Received April 29, 2015

    Report

    Report Number
    1644487-2015-04583
    Event Type
    Death
    Date Received
    April 29, 2015
    Date of Event
    July 15, 2014
    Report Date
    April 6, 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

    Description of Event or Problem · 1

    IT WAS REPORTED ON 04/06/2015 THAT THE PATIENT PASSED AWAY ON (B)(6) 2014 FROM INFLAMMATORY BREAST CANCER. THE NEUROLOGIST WHO THE PATIENT LAST SAW IS NO LONGER PRACTICING. FOLLOW-UP WITH THE FUNERAL HOME SHOWED THAT THE PATIENT WAS BURIED WHICH MEANS THAT SHE WOULD NOT HAVE HAD THE DEVICE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280552 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS INC 101 1765

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death