BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG FUTURE BAND

    MDR report key: 7966288 · Received October 15, 2018

    Report

    Report Number
    2025587-2018-02735
    Event Type
    Injury
    Date Received
    October 15, 2018
    Date of Event
    March 21, 2018
    Report Date
    October 19, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    UDI-DI
    00613994758774
    PMA / PMN Number
    K052860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. WITHOUT THE RETURN OF THE PRODUCTS, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 690R32, SERIAL/LOT #: (B)(4), UBD: 21-APR-2021 UDI#: (B)(4), PMA/510K #: K101212. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT EIGHT DAYS POST IMPLANT OF THIS ANNULOPLASTY RING AND ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805357 CG FUTURE BAND RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 638BL28 00613994758774

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention