BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 5069511 · Received September 10, 2015

    Report

    Report Number
    2124215-2015-11681
    Event Type
    Death
    Date Received
    September 10, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DEVELOPED AN INFECTION. DURING THE PROCEDURE TO EXPLANT THE SYSTEM, THE SUPERIOR VENA CAVA WAS TORN WHEN PERFORMING A LASER EXTRACTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM ON BYPASS BUT SUBSEQUENTLY DIED. THE PRODUCT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600759 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0275

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death| H| L| R