BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM

    MDR report key: 8778000 · Received July 10, 2019

    Report

    Report Number
    2025587-2019-02194
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    April 29, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00643169121676
    PMA / PMN Number
    K093903
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 638BL32, SERIAL/LOT #: (B)(4), UBD: 06-FEB-2024, UDI #: (B)(4), PMA/510(K): K011395. PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE STRUCTURAL HEART PRODUCT). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS FOLLOWING THE IMPLANT OF THESE ANNULOPLASTY PRODUCTS, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIAL FIBRILLATION, ATRIAL FLUTTER AND ATRIAL TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569970 RING ANNULOPLSTY TRICUSP CONTOUR 3D 26MM RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 690R26 00643169121676

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention