BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 2071227 · Received April 27, 2011

    Report

    Report Number
    2015691-2011-15347
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K082139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: DESPITE MULTIPLE FOLLOW-UP ATTEMPTS WITH HEALTHCARE PROVIDER, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE CAUSE OF PATIENT'S DEATH, MEDICAL HISTORY, AND DEVICE STATUS. THE DEVICE HISTORY RECORD REVIEW WILL BE REPORTED ONCE COMPLETED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT THE PATIENT HAS EXPIRED; THE CAUSE OF DEATH AS WELL AS DATE HAVE NOT BEEN PROVIDED DESPITE MULTIPLE FOLLOW-UPS WITH HEALTHCARE PROVIDER. PATIENT HAD ANOTHER PERICARDIAL PATCH IMPLANTED, PLEASE REFERENCE MFR REPORT # 2015691-2011-15346.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 8B0289

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death