BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK SQ

    MDR report key: 1654345 · Received April 7, 2010

    Report

    Report Number
    2124215-2010-08048
    Event Type
    Death
    Date Received
    April 7, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS SUB-Q ARRAY LEAD PASSED AWAY DURING A REVISION PROCEDURE. THE PATIENT HAD A COMPETITOR'S DEVICE. THIS LEAD WAS SUCCESSFULLY IMPLANTED; HOWEVER, DURING DEFIBRILLATION THRESHOLD (DFT) TESTING, THERE WAS NO CAPTURE. THE IMPEDANCE AND THRESHOLD MEASUREMENTS WERE WITHIN NORMAL LIMITS FOR THIS LEAD. THE LOCAL FIELD REPRESENTATIVE WAS CALLED BACK TO THE OR WHERE A NURSE HAD BEGUN CHEST COMPRESSIONS. THE FIELD REPRESENTATIVE ATTEMPTED TO INTERROGATE THE DEVICE; HOWEVER, IT TOOK 10 MINUTES TO BOOT UP THE COMPETITOR'S PROGRAMMER. CHEST COMPRESSIONS WERE STOPPED FOR A SHORT TIME TO FIND UNDERLYING RHYTHM, WHICH WAS VENTRICULAR FIBRILLATION AND THE DEVICE WAS NOT SHOCKING AND THERE WAS NO CAPTURE. THE PROGRAMMER EVENTUALLY BOOTED UP AND THE COMPETITOR'S REPRESENTATIVE BEGAN STAT SHOCKING; HOWEVER, THE PATIENT PASSED AWAY. IT IS UNCERTAIN IF THE LEAD WILL BE RETURNED AS THERE IS AN ONGOING HOSPITAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK SQ IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0085

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death 0085