BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG FUTURE BAND

    MDR report key: 6188122 · Received December 20, 2016

    Report

    Report Number
    2025587-2016-02046
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    October 26, 2014
    Report Date
    January 11, 2017
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    KRH
    UDI-DI
    00613994758798
    PMA / PMN Number
    K052860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. WITHOUT THE RECEIPT OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO NEW INFORMATION HAS BEEN RECEIVED TO DATE.

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS 30MM ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED DUE TO SEVERE SYSTOLIC ANTERIOR MOTION (SAM) WITH SEVERE REGURGITATION. THE PHYSICIAN THOUGHT THIS BAND WAS TOO SMALL, SO IT WAS REPLACED WITH A 34MM ANNULOPLASTY BAND. AFTER REPLACEMENT WITH A 34MM BAND, NO SAM AND NO REGURGITATION WAS PRESENT. PATIENT'S RELEVANT MEDICAL HISTORY UPDATED. PATIENT AND DEVICE CODES UPDATED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

    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 IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY BAND IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED. NO FAILURE MECHANISM AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841305 CG FUTURE BAND RING, ANNULOPLASTY KRH HEART VALVES SANTA ANA 638B 00613994758798

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention