BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIBRILLATING DEVICE

    MDR report key: 83748 · Received April 9, 1997

    Report

    Report Number
    83748
    Event Type
    Death
    Date Received
    April 9, 1997
    Date of Event
    October 26, 1996
    Report Date
    April 1, 1997
    Manufacturer
    UNK
    Product Code
    LIW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR CARDIAC CATHETERIZATION ON 10/22/96. PT UNDERWENT SURGERY ON 10/23/96 FOR MITRAL VALVE REPLACEMENT USING A RIGHT THORACOTOMY APPROACH. THE HEART WAS FIBRILLATED DURING THE INITIAL SURICAL PROCEDURE FOR APPROX 3 1/2 HRS. AT THE CONCLUSION OF FIBILLATION PT DEVELOPED POOR LEFT VENTRICULAR FUNCTION THAT NECESSITATED PLACEMENT OF A BILATERAL VENTRICULAR ASSISTIVE DEVICE. ON FUTURE REVIEW, THERE WAS A QUESTION WHETHER THE FIBRILLATING DEVICE CONTRIBUTED TO THE SURGERY DUE TO CARDIAC TAMPONADE. THE PT EXPIRED 10/26/96. AUTOPSY REPORT REVEALED: MASSIVE CIRCUMFERENTIAL MYOCARDIAL INFARCTION INVOLVING BASE OF LEFT VENTRICLE WITHOUT SIGNIFICANT CORONARY ARTERY DISEASE. BILATERAL PULMONARY PASSIVE CONGESTION, EDEMA AND EARLY PNEUMONITIS. MICROEMPHYSEMA, MODERATE PASSIVE CONGESTION OF LIVER, BILATERAL MILD CHRONIC PYELONEPHRITIS, SOFT TISSUE EDEMA, STATUS POSTOPERATIVE: PORCINE MITRAL VALVE REPLACEMENT, BIVENTRICULAR ASSIST DEVICE PLACEMENT, MEDIASTINOTOMY FOR EVACUATION OF PERICARDIAL BLOOD CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBRILLATING DEVICE FIBRILLATING DEVICE LIW UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death THORATEC BILATERAL VENTRICULAR ASSIST DEVICE| (10/23/96 TO 10/26/96)