BEUDAMED
    FDA Adverse Event Death Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1690754 · Received May 16, 2010

    Report

    Report Number
    2015691-2010-13366
    Event Type
    Death
    Date Received
    May 16, 2010
    Date of Event
    January 28, 2010
    Report Date
    April 14, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE EVENT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED; (B) (6). THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER (VIA FAX), ADDITIONAL INFORMATION AND THE OPERATIVE REPORT WAS RECEIVED. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED ON (B) (6) 2010. ON 04/16/2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), A RESPONSE WAS RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED. PER THE OPERATIVE REPORT OF (B) (6) 2009, THE OPERATION WAS COMPLETED AND "SHE WAS RETURNED TO THE INTENSIVE CARE UNIT IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 R-09F1362

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death