BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 1737484 · Received June 26, 2010

    Report

    Report Number
    2015691-2010-13634
    Event Type
    Death
    Date Received
    June 26, 2010
    Date of Event
    April 14, 2010
    Report Date
    June 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K082139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER VIA FAX, COPIES OF THE PATIENT'S OPERATIVE REPORTS FOR PROCEDURES ON 01/29/2010 AND 02/03/2010 WERE RECEIVED. UNFORTUNATELY, THE CAUSE OF DEATH WAS NOT PROVIDED.

    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. TWO REQUESTS WERE MADE TO THE HEALTH-CARE PROVIDER (VIA FAX) FOR THE DEVICE, OPERATIVE REPORT, AND ADDITIONAL INFORMATION (ON 06/07/2010 AND 06/11/2010); HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF DEATH REMAINS UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW HAS BEEN COMPLETED AND THERE WERE NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS EXPIRED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2.53 MONTHS, DUE TO UNKNOWN REASONS. IT IS UNKNOWN IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    FOUR FALSELY ELEVATED ECREA RESULTS WERE OBTAINED ON PATIENTS' SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED ECREA RESULTS.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A LEAK WHICH OCCURRED AT THE CONNECTION BETWEEN GANG AND STOPCOCK AFTER 2 HOURS OF USAGE. THE 3 GANG MANIFOLD WAS CONNECTED WITH A FILLING DEVICE (A FILLING SYRINGE) IN WHICH DIPRIVAN 2 % WAS INJECTED. SMALL CRACKS APPEARED IN THE STOPCOCK AND THE DIPRIVAN LEAKED OUT. THE FLOW OF THE INJECTOR WAS 5 AT 10 ML/HR. THE REPORTED CONDITION OCCURRED DURING USE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-09K2436

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death