BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXTRUS 4136

    MDR report key: 1131805 · Received August 21, 2008

    Report

    Report Number
    1028232-2008-00978
    Event Type
    Death
    Date Received
    August 21, 2008
    Date of Event
    March 27, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS BSC SALES REPRESENTATIVE (SR) CALLED TECHNICAL SERVICES (TS) REPORTING THAT DURING THIS INITIAL IMPLANT PROCEDURE, THE PATIENT'S HEART RATE WAS BEATING AT 115BPM. THE RIGHT VENTRICULAR (RV) LEAD 4136 WAS PLACED AND HAD APPROPRIATE CAPTURE. WHILE THE PHYSICIAN WAS TYING DOWN THE RV LEAD, THE PATIENT'S HEART RATE DROPPED DUE TO METROPROLOL, THE PATIENT'S EYES DILATED AND HER BLOOD PRESSURE DROPPED TO 30/20. THE PHYSICIAN CONNECTED THE PACEMAKER TO BRING THE PATIENT'S HEART RATE TO 60PPM, HOWEVER, PATIENT CODED. AN ECHOCARDIOGRAM WAS PERFORMED, RULING OUT TAMPONADE. AFTER 30 MINUTES, THE PATIENT DIED. THE PHYSICIAN SUSPECTS THE PATIENT'S DEATH WAS DUE TO A CLOT. THERE WERE NO ALLEGATIONS AGAINST THE PRODUCTS. AN AUTOPSY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4136 PACER LEAD DTB BIOTRONIK GMBH AND CO. 358754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death