BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE LEAD MRI SURESCAN

    MDR report key: 22202017 · Received June 13, 2025

    Report

    Report Number
    2649622-2025-16083
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 28, 2025
    Report Date
    September 1, 2025
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169448865
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. 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.

    Additional Manufacturer Narrative · 0

    A070910 FDD REMOVED AS IT WAS NOT RELATED TO THIS RECORD. 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 RIGHT ATRIAL (RA) LEAD WAS UNDER SENSING AND HAD BEEN PROGRAMMED DDI. IT WAS ALSO REPORTED THAT VENTRICULAR SENSING ON CURRENT ELECTROGRAMS (EGM) APPEARED ONLY WHEN ATRIAL PACING, THEREFORE FUNCTIONAL CROSS CHAMBER BLANKING WAS SUSPECTED. THE RA AND RIGHT VENTRICULAR (RV) LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376920 CAPSURE SENSE LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MPRI 407458 00643169448865

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention 457453 LEAD, W1DR01 IPG.