BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    MDR report key: 1665179 · Received April 22, 2010

    Report

    Report Number
    2015691-2010-13192
    Event Type
    Death
    Date Received
    April 22, 2010
    Report Date
    March 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. THIS EVENT WAS DETERMINED TO BE REPORTABLE PER EDWARDS LIFESCIENCES PROCEDURES. THE INFORMATION WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY. THE PATIENT ALSO HAD ANOTHER DEVICE IMPLANTED; (B) (4). TWO REQUESTS HAVE BEEN MADE (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE HEALTH-CARE PROVIDER. UNFORTUNATELY, THE CAUSE OF DEATH REMAINS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED. NO FURTHER DETAILS WERE REPORTED. THE CAUSE OF DEATH, DATE OF DEATH, AND IMPLANT DURATION REMAIN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 2800 6B0245

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death