BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 19012535 · Received April 1, 2024

    Report

    Report Number
    2182208-2024-01405
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    May 24, 2023
    Report Date
    April 1, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 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. REFERENCED ARTICLE: CONSECUTIVE EXPERIENCE WITH LEFT BUNDLE BRANCH AREA PACING IN A HIGH-VOLUME AUSTRALIAN CENTRE. HEART, LUNG AND CIRCULATION. 2023; 32, 993¿999. DOI: 10.1016/J.HLC.2023.04.293 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 LEFT-BUNDLE BRANCH AREA PACING (LBBAP). THE AUTHORS DESCRIBED ONE PATIENT DEATH. THE DEATH WAS SUDDEN AND PRESUMED CARDIAC RELATED, IN A PATIENT WITH MILD ISCHEMIC CARDIOMYOPATHY AND ONE HEART FAILURE ADMISSION THREE MONTHS POST LBBAP IMPLANT. THERE WERE PATIENTS WHO EXPERIENCED NEW POST-PROCEDURAL SEVERE TRICUSPID REGURGITATION (TR), HEART FAILURE HOSPITALIZATIONS, ONE STROKE, AND A DEVICE INFECTION WHICH REQUIRED SYSTEM EXPLANT, IN THE SETTING OF AN EXISTING PERMANENT CENTRAL LINE THAT BECAME INFECTED. THERE WERE LEADS WHICH EXHIBITED A SLIGHT REDUCTION IN IMPEDANCE AND RISES IN THRESHOLDS WITH ONE THAT REQUIRED A LEAD REVISION. 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
    1589368 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male UNKNOWN CIED AND LEADS