BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA MRI XT DR SURESCAN

    MDR report key: 23490260 · Received November 6, 2025

    Report

    Report Number
    9614453-2025-04461
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 14, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    UDI-DI
    00763000059521
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0180 LEAD IMPLANTED: (B)(6) 2007, 407645 LEAD IMPLANTED (B)(6) 2005. 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 THAT THE PATIENT PRESENTED WITH EROSION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562683 EVERA MRI XT DR SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC EUROPE SARL DDMB1D1 00763000059521

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| H