BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE LEAD MRI SURESCAN

    MDR report key: 23659489 · Received November 26, 2025

    Report

    Report Number
    2182208-2025-10581
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    January 1, 2025
    Report Date
    November 26, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS UNKNOWN/64 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: EFFICACY OF LEFT BUNDLE BRANCH AREA PACING-BASED CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE. JOURNAL OF CLINICAL CARDIOLOGY (CHINA). 2025. 41(5): 376-381. DOI: 10.13201/J.ISSN.1001-1439.2025.05.010. 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

    LITERATURE WAS REVIEWED REGARDING LEFT BUNDLE BRANCH AREA PACING (LBBAP) AND CARDIAC RESYNCHRONIZATION THERAPY. THE AUTHORS DESCRIBED ONE PATIENT WHO DEVELOPED AN INFECTION AND THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED. THREE PATIENTS WERE READMITTED TO THE HOSPITAL DUE TO HEART FAILURE AND WERE DISCHARGED AFTER AN ADJUSTMENT TO THEIR MEDICATION. THERE WERE LEADS THAT WERE ATTEMPTED, NOT IMPLANTED DUE TO HIGH THRESHOLDS. THE STATUS OF THE DEVICES AND LEADS IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673148 CAPSURE SENSE LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention| H UNKNOWN CRT-P AND LEADS.