BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1696202 · Received May 20, 2010

    Report

    Report Number
    2124215-2010-11303
    Event Type
    Death
    Date Received
    May 20, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT FOLLOWING THE PLACEMENT OF THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD THE PT STOPPED BREATHING AND WENT INTO VENTRICULAR FIBRILLATION. SUBSEQUENTLY, THERE WAS ELECTRO-MECHANICAL DISASSOCIATION. CARDIOPULMONARY RESUSCITATION WAS PERFORMED FOR ONE HOUR BUT WAS UNSUCCESSFUL AND THE PT DIED. THE RV LEAD WAS ABANDONED, AND IT IS SUSPECTED THAT IT WAS BURIED WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death 0184| 4591