BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA MRI XT DR SURESCAN

    MDR report key: 24313184 · Received February 11, 2026

    Report

    Report Number
    3004209178-2026-02224
    Event Type
    Death
    Date Received
    February 11, 2026
    Date of Event
    October 1, 2025
    Report Date
    February 11, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169720497
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT THE PATIENT WAS IN HOSPICE CARE AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ¿GONE OFF¿ TEN TIMES IN THE PAST THREE MONTHS AND WAS ¿TORTURING¿ THE PATIENT AND THAT EVERY TIME THE ICD DELIVERED A SHOCK, THE PATIENT GOT ¿MORE BRAINDEAD¿. THE PATIENT PASSED AWAY A WEEK LATER AND THE PATIENT¿S SPOUSE STATED THAT THE ICD SHOCKED THE PATIENT EVEN AFTER THEY PASSED. A CAUSE OF DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377952 EVERA MRI XT DR SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDMB1D4 00643169720497

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death 5076-52 LEAD, 6947M62 LEAD