BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CG FUTURE BAND

    MDR report key: 3083194 · Received April 29, 2013

    Report

    Report Number
    2025587-2013-00068
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    January 18, 2013
    Report Date
    April 2, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    KRH
    PMA / PMN Number
    K011395
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE DEVICE HAS BEEN REQUESTED BUT NOT YET RECEIVED. THEREFORE, NO ANALYSIS HAS BEEN PERFORMED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(6). (B)(4).

    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 FOUR YEARS AND ONE MONTH FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY BAND, IT WAS EXPLANTED DUE TO A LEAK IN THE MITRAL VALVE. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184917 CG FUTURE BAND RING, ANNULOPLASTY KRH HEART VALVES SANTA ANA 638B

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention