BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 1652808 · Received April 5, 2010

    Report

    Report Number
    2124215-2010-07026
    Event Type
    Death
    Date Received
    April 5, 2010
    Date of Event
    March 20, 2010
    Report Date
    March 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED; FOUR DAYS POST ARREST, THE PATIENT DIED. IT WAS THOUGHT THE PATIENT DIED DUE TO REDUCED CARDIAC OUTPUT CAUSED BY THE MANEUVERS DURING RESUSCITATION. THERE WAS NO ALLEGATION AGAINST THE BOSTON SCIENTIFIC CRM DEVICE. AT THIS TIME, IT IS UNKNOWN WHETHER THE DEVICE WILL BE RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, A DISSECTION OF THE CORONARY SINUS OCCURRED. REPORTEDLY, THIS WAS CAUSED BY THE NON-BOSTON SCIENTIFIC CRM DIAGNOSTIC CATHETER'S RIGID TIP. THE DISSECTION WAS CONFIRMED BY CONTRAST IMAGING. THERE WAS NO ALLEGATION AGAINST THE BOSTON SCIENTIFIC CRM PRODUCT. POST PROCEDURE, THE PATIENT DISPLAYED LOW BLOOD PRESSURE, JUGULAR TURGOR AND PERSPIRATION; AN ECHOCARDIOGRAPHY CONFIRMED A CARDIAC TAMPONADE. THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO PERFORM A PERICARDIOCENTESIS; HOWEVER, DURING THAT PROCEDURE, THE RIGHT VENTRICLE WAS PERFORATED. THE PATIENT'S CONDITION WORSENED AND THE PATIENT HAD A CARDIAC ARREST AND WAS SUCCESSFULLY RESUSCITATED. AFTER THIRTY MINUTES; THE PATIENT STABILIZED; A SECOND SUCCESSFUL PERICARDIOCENTESIS PROCEDURE WAS PERFORMED. THE BLOOD WAS REMOVED; HOWEVER, NEW BLEEDING WAS NOTED FROM THE PERICARDIAL DETACHMENT AREA. THE PATIENT WAS RETURNED TO THE CARDIOSURGERY ROOM; THE CORONARY SINUS DISSECTION WAS CONFIRMED. IN ADDITION, LEFT VENTRICLE LESIONS AND RIGHT VENTRICLE LESIONS WERE REVEALED AND WERE SUCCESSFULLY REPAIRED. THIS DEVICE REMAINED IMPLANTED AND IN SERVICE; THE PATIENT REMAINED HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR LWS GUIDANT CRM CLONMEL IRELAND H140

    Patients

    Seq Age Sex Outcome Treatment
    1 Death