BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 21540581 · Received March 6, 2025

    Report

    Report Number
    2182208-2025-01161
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    December 1, 2024
    Report Date
    March 6, 2025
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 CHARACTERISTICS IS MALE. 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: COMPARISON OF PROCEDURAL OUTCOMES OF LUMENLESS FIXED-HELIX VERSUS STYLET-DRIVEN EXTENDABLE-HELIX LEAD SYSTEMS IN LEFT BUNDLE BRANCH PACING: COMPARE LBBP. CIRCULATION: ARRHYTHMIA AND ELECTROPHYSIOLOGY. 2024; 17:E013385. DOI: 10.1161/CIRCEP.124.013385. 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. 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 PACING (LBBP). THE AUTHORS DESCRIBED TWO LEADS DURING THE IMPLANT PROCEDURE THAT HAD TISSUE TRAPPED IN THE HELIX DURING REPEATED ATTEMPTS AND WERE REPLACED WITH DIFFERENT LEADS. ONE LEAD WAS REPOSITIONED DUE TO MICRO DISLODGMENT AFTER SLITTING AND ONE PATIENT EXPERIENCED SEPTAL PERFORATION AND THE LEAD WAS REPOSITIONED. POST IMPLANT, THERE WERE PATIENTS THAT DEVELOPED RIGHT BUNDLE BRANCH BLOCK AND ONE PATIENT WITH WORSENED TRICUSPID REGURGITATION. THERE WAS ONE LEAD DISLODGEMENT WHICH REQUIRED A LEAD REVISION. THERE WERE LEADS WHICH EXHIBITED INCREASES IN THRESHOLDS, MICRO DISLODGMENTS, AND LOSS OF CAPTURE. 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
    799909 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R| L UNKNOWN COMPETITOR CIED AND LEADS