BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMUPLUS

    MDR report key: 22575732 · Received July 23, 2025

    Report

    Report Number
    9612164-2025-03594
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    August 28, 2024
    Report Date
    July 23, 2025
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    KRH
    UDI-DI
    00763000271336
    PMA / PMN Number
    K201449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 8 MONTHS POST IMPLANT OF THIS 36MM MITRAL ANNULOPLASTY BAND, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED MODERATE MITRAL REGURGITATION WITH A CENTRAL JET. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870919 SIMUPLUS RING, ANNULOPLASTY KRH MEDTRONIC MEXICO 7700FB36 00763000271336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male