BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS SEMI-RIGID ANNULOPASTY RING

    MDR report key: 10138694 · Received June 10, 2020

    Report

    Report Number
    2025587-2020-01850
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 10, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00643169182288
    PMA / PMN Number
    K072655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8 00SR28, SERIAL/LOT #: (B)(4), PMA #: K072655, UBD: 14-MAR-2024, UDI#: (B)(4). PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THIS SURGERY A 28MM AND 30MM MITRAL ANNULOPLASTY RING OF THE SAME MODEL WERE ATTEMPTED TO BE USED, BUT ULTIMATELY THE VALVE WAS REPLACED WITH A NON-MEDTRONIC PRODUCT. THE REASON THE ANNULOPLASTY DEVICES WERE NOT USED WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602162 SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 800SR30 00643169182288

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention