BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA MRI XT DR

    MDR report key: 17950720 · Received October 16, 2023

    Report

    Report Number
    MW5147053
    Event Type
    Death
    Date Received
    October 16, 2023
    Report Date
    October 11, 2023
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND DIED ON (B)(6) 2020. HE HAD AN ICD (IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR) IMPLANT WHICH FAILED TO GIVE ANY SHOCK THERAPY SINCE PLACED IN 2016. IT DID PACE A FEW TIMES. THE ICDS LAST TRANSMISSION WAS (B)(6) 2020. I DO NOT KNOW WHY THE BOX WAS NOT ON AFTER THIS DATE. I DO BELIEVE MY HUSBAND COULD STILL BE LIVING IF THE ICD WERE TO HAVE ISSUED THERAPY AT THE TIME OF HIS HEART ATTACK WHICH KILLED HIM. HE HAD AN EVERA MRI XT DR DEFIBRILLATOR. I WOULD GREATLY APPRECIATE ANY HELP AT ALL WITH THIS SITUATION. I DON'T HAVE THE ACTUAL ICD THAT WAS IMPLANTED, BUT I DO STILL HAVE 2 HANDHELD DEVICES THAT HE HELD UP TO THE DEVICE TO SEND READINGS. IF YOU HAVE ANY QUESTIONS, PLEASE CONTACT ME AT ANY TIME. (B)(6). REFERENCE REPORT: MW5147054, MW5147055.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82814 EVERA MRI XT DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC. DDMB1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death