BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 21452764 · Received February 24, 2025

    Report

    Report Number
    2649622-2025-05301
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    December 1, 2024
    Report Date
    February 24, 2025
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: REFERENCED ARTICLE: LEFT BUNDLE BRANCH AREA PACING COMPARED TO RIGHT VENTRICULAR OUTFLOW TRACT SEPTAL PACING: MID-TERM RESULTS AND LEARNING CURVE. THE JOURNAL OF INNOVATIONS IN CARDIAC RHYTHM MANAGEMENT. 2024; 15(12):6113¿6121. DOI: 10.19102/ICRM.2024.15123 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) COMPARED TO RIGHT VENTRICULAR OUTFLOW TRACT SEPTAL PACING (RVOSP). THE AUTHORS DESCRIBED ONE LEAD DISLODGMENT WHICH REQUIRED A REVISION. THE STATUS OF THE LEAD IS UNKNOWN. NO ADVERSE PATIENT EFFECTS OR ADDITIONAL PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349994 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R A3DR01 IPG