BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 20746863 · Received November 21, 2024

    Report

    Report Number
    2182208-2024-04955
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    June 21, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 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 FEMALE/72 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: HIS BUNDLE PACING VERSUS LEFT BUNDLE BRANCH AREA PACING IN PATIENTS UNDERGOING ATRIOVENTRICULAR NODE ABLATION: A PROSPECTIVE AND COMPARATIVE STUDY. ARCHIVES OF CARDIOVASCULAR DISEASE. 2024. 117: 505¿513. DOI: 10.1016/J.ACVD.2024.05.118 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 HIS BUNDLE PACING (HBP) VERSUS LEFT BUNDLE BRANCH AREA PACING (LBBAP) IN PATIENTS UNDERGOING ATRIO VENTRICULAR NODE ABLATION (AVNA). THE AUTHORS DESCRIBED PATIENT DEATHS; THE CAUSES OF DEATH WERE REFRACTORY HEART FAILURE, ACUTE PULMONARY EMBOLISM, AND OTHER UNKNOWN CAUSES. DURING THE AVNA PROCEDURE, THERE WERE ACUTE TRANSIENT THRESHOLD INCREASES IN THE HBP GROUP. ONE LBBAP LEAD DISLODGEMENT OCCURRED AT ONE MONTH; A CONVENTIONAL LEAD WAS REPOSITIONED AT THE RIGHT VENTRICLE SEPTUM. IN THE HBP GROUP, VENTRICULAR LEAD REVISION OCCURRED IN ONE PATIENT AT ONE-YEAR FOLLOW-UP DUE TO A PROGRESSIVE HBP THRESHOLD ELEVATION. THERE WERE PATIENT HOSPITALIZATIONS DUE TO HEART FAILURE IN BOTH GROUPS. THERE WERE OTHER LEADS WHICH EXHIBITED A DECREASE IN IMPEDANCE OR AN INCREASE IN HBP THRESHOLD. 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
    2430613 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female UNKNOWN COMPETITOR CIED