BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSECURE MRI SURESCAN

    MDR report key: 19920725 · Received August 6, 2024

    Report

    Report Number
    2182208-2024-03191
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 6, 2024
    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/69 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: PERSONALIZED CARDIAC RESYNCHRONIZATION THERAPY GUIDED BY REAL-TIME ELECTROCARDIOGRAPHIC IMAGING FOR PATIENTS WITH NON¿LEFT BUNDLE BRANCH BLOCK. HEART RHYTHM. 2024; 21:1047¿1056. DOI: 10.1016/J.HRTHM.2024.02.027 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 CARDIAC RESYNCHRONIZATION THERAPY (CRT) IMPLANTATION. THE AUTHORS DESCRIBED TWO PATIENT DEATHS DUE TO DECOMPENSATED HEART FAILURE ONE MONTH AFTER THE IMPLANT PROCEDURE. THEY WERE CLASSIFIED AS CLINICAL AND ECHOCARDIOGRAPHIC NON-RESPONDERS. THERE IS NO ALLEGATION OF LEAD-DEATH RELATEDNESS INDICATED IN THE ARTICLE. THERE WAS ONE PATIENT WHO EXPERIENCED STAPHYLOCOCCUS AUREUS SEPTICEMIA THREE MONTHS AFTER THE IMPLANT PROCEDURE. THE LEAD WAS REMOVED. THERE WAS ONE HIS-BUNDLE PACING (HBP) LEAD WHICH EXHIBITED AN INCREASE IN 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
    1560194 SELECTSECURE MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) NVN MEDTRONIC, INC. 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male UNKNOWN COMPETITOR CRT