BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERA MRI XT DR SURESCAN

    MDR report key: 22956700 · Received September 3, 2025

    Report

    Report Number
    3004209178-2025-14914
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 3, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169837713
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0186 LEAD IMPLANTED: (B)(6) 2007, 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 THAT PATIENT EXPERIENCED PACEMAKER MEDIATED TACHYCARDIA (PMT). REPROGRAMMING OCCURRED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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
    1734149 EVERA MRI XT DR SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDMB1D1 00643169837713

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention 5076-52 LEAD.