BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND

    MDR report key: 4931968 · Received July 22, 2015

    Report

    Report Number
    2025587-2015-00771
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K052899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WERE REQUESTED, HOWEVER WERE UNSUCCESSFUL. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    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 THIS ANNULOPLASTY BAND WAS EXPLANTED IMMEDIATELY FOLLOWING ITS IMPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL EVENT INFORMATION WAS REQUESTED, BUT NO INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474571 SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 700FC25

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention