BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 22510009 · Received July 15, 2025

    Report

    Report Number
    2182208-2025-03430
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 1, 2025
    Report Date
    July 15, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. 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: CLINICAL OUTCOMES AND ELECTROPHYSIOLOGICAL CHARACTERISTICS OF PARTIAL PERFORATION AFTER LEFT BUNDLE BRANCH AREA PACING. JACC CLINICAL ELECTROPHYSIOLOGY. 2025; 11:1279¿1289. DOI: 10.1016/J.JACEP.2025.01.016. 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 PARTIAL PERFORATIONS AFTER LEFT BUNDLE BRANCH AREA PACING. THE STUDY INCLUDED HUMAN PARTICIPANTS AND AN EXPERIMENTAL SWINE STUDY. THE AUTHORS DESCRIBED ELEVEN PATIENT DEATHS; THE CAUSES OF DEATH WERE DUE TO NONCARDIOVASCULAR CAUSES IN NINE AND TWO WERE DUE TO HEART FAILURE. THERE IS NO ALLEGATION OF LEAD-DEATH RELATEDNESS INDICATED IN THE ARTICLE; HOWEVER, THE CAUSE OF DEATH AND LEAD-DEATH RELATEDNESS HAS BEEN REQUESTED, BUT NOT YET RECEIVED. THERE WERE PATIENTS WHO EXPERIENCED COMPLETE AND PARTIAL PERFORATIONS WHICH REQUIRED LEAD REPOSITIONING. ONE PATIENT DEVELOPED A CEREBRAL EMBOLISM CAUSED BY ATRIAL FIBRILLATION (AF) DURING THE FOLLOW-UP PERIOD. THERE WERE LEADS WHICH EXHIBITED LOSS OF CAPTURE, INCREASED CAPTURE THRESHOLDS, AND DECREASED IMPEDANCE. IN THE SWINE MODELS, FOUR LEADS WERE IMPLANTED WITH TWO PARTIAL PERFORATIONS AND ONE COMPLETE PERFORATION. THE STATUS OF THE 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
    154846 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN COMPETITOR CIED.