BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERA MRI XT DR SURESCAN

    MDR report key: 25302800 · Received May 27, 2026

    Report

    Report Number
    9614453-2026-02100
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    October 1, 2024
    Report Date
    May 27, 2026
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    UDI-DI
    00763000059521
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0185 LEAD, IMPLANTED (B)(6) 2011. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THEY HAVE BEEN HAVING PROBLEMS WITH THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT NOTED THAT THEY HAVE ¿LANDED IN THE HOSPITAL THREE TIMES SHOWING AN ARRHYTHMIA¿ AND THE ICD ¿SHOWS BIG PEAKS AND THEN IT SHUTS OFF BY ITSELF.¿ THE PATIENT ALSO NOTED THAT THEY DO NOT FEEL GOOD A LOT OF TIMES AND THEIR ¿BLOOD PRESSURE GOES UP AND STOPS BY ITSELF.¿ THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528342 EVERA MRI XT DR SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC EUROPE SARL DDMB1D1 00763000059521

    Patients

    Seq Age Sex Outcome Treatment
    1