BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1850770 · Received October 2, 2010

    Report

    Report Number
    2015691-2010-14141
    Event Type
    Injury
    Date Received
    October 2, 2010
    Date of Event
    June 28, 2010
    Report Date
    September 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REGISTRY DOCUMENTS THIS AS REPORT ONLY. CUSTOMER LETTER NOT REQUESTED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE (ANNULOPLASTY RING) WAS EXPLANTED AFTER AN IMPLANT DURATION OF 10.37 MONTHS DUE TO UNKNOWN REASONS. [A VALVE] THE 6900PJ29 WAS IMPLANTED AS A REPLACEMENT. NO FURTHER DETAILS WERE PROVIDED. INFORMATION WAS LEARNED THROUGH (B)(4) IMPLANT PATIENT REGISTRY. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY SYSTEM KRH EDWARDS LIFESCIENCES 4600 09A021

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R