BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 22372389 · Received July 1, 2025

    Report

    Report Number
    2182208-2025-03176
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    January 1, 2024
    Report Date
    July 1, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/63 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: COMPARISONS OF LONG-TERM CLINICAL OUTCOMES WITH LEFT BUNDLE BRANCH PACING, LEFT VENTRICULAR SEPTAL PACING, AND BIVENTRICULAR PACING FOR CARDIAC RESYNCHRONIZATION THERAPY. HEART RHYTHM. 2024; 21:1342¿1353. DOI: 10.1016/J.HRTHM.2024.03.007 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 LONG-TERM CLINICAL OUTCOMES WITH LEFT BUNDLE BRANCH PACING (LBBP), LEFT VENTRICULAR SEPTAL PACING (LVSP), AND BIVENTRICULAR PACING (BIVP) FOR CARDIAC RESYNCHRONIZATION THERAPY. THE AUTHORS DESCRIBED PATIENT DEATHS IN ALL THREE GROUPS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN AND DESCRIBED AS ALL-CAUSE WITH CARDIAC AND NON-CARDIAC DEATHS. THERE WERE PATIENTS WHO EXPERIENCED WORSENING HEART FAILURE SYMPTOMS WHICH REQUIRED ORAL OR INTRAVENOUS (IV) DIURETICS WITH HOSPITALIZATIONS IN ALL GROUPS, PHRENIC NERVE STIMULATION AND ONE PNEUMOTHORAX WHICH ONLY OCCURRED IN THE BIVP GROUP, AND INFECTIONS WHICH OCCURRED IN THE BIVP AND LVSP GROUPS. THERE WERE LEADS IN THE BIVP AND LVSP GROUPS WHICH EXHIBITED DISLODGMENTS AND INCREASED CAPTURE THRESHOLDS. 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
    1215082 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male UNKNOWN COMPETITOR CRT