BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 24161327 · Received January 23, 2026

    Report

    Report Number
    2182208-2026-01109
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    November 7, 2024
    Report Date
    January 23, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. 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: INADVERTENT IMPLANTATION OF A CONDUCTION SYSTEM PACING LEAD INTO THE LEFT VENTRICLE VIA PATENT FORAMEN OVALE IN A DUAL-CHAMBER PACEMAKER. POLISH HEART JOURNAL. 2024. 1297-1299. DOI: 10.33963/V.PHJ.103318 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 A LEAD TIP IN THE LEFT VENTRICLE. THE AUTHORS DESCRIBED A PATIENT WHO UNDERWENT A DRUG-ELUTING STENT IMPLANTATION AND A CORONAROGRAPHY AND ROUTINE ECHOCARDIOGRAM REVEALED THE LEAD TIP OF THE LEFT BUNDLE BRANCH AREA PACING (LBBAP) LEAD IN THE LEFT VENTRICLE. THE LEAD HAD DISLODGED/MIGRATED VIA THE PATENT FORAMEN OVALE AND THE MITRAL VALVE, WITH ITS TIP IN THE BASAL PART OF THE LATERAL WALL OF THE LEFT VENTRICLE. A BRAIN COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH CONTRAST WAS PERFORMED AND SHOWED NO ISCHEMIC LESIONS. THE LEAD WAS EXPLANTED AND REPLACED WITH NO THROMBUS NOTED IN THE LEFT VENTRICULAR CHAMBERS OR ANYTHING ATTACHED TO THE LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219606 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| H UNKNOWN COMPETITOR IPG AND LEAD