BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2083586 · Received May 10, 2011

    Report

    Report Number
    2124215-2011-08228
    Event Type
    Death
    Date Received
    May 10, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT'S SPOUSE THAT THIS PATIENT DIED IN AN EMERGENCY ROOM AFTER RECEIVING A SHOCK AND PASSING OUT. THE SPOUSE REPORTED THE DEVICE WAS NOT INTERROGATED AFTER THE PATIENT'S DEATH, AND WAS BURIED WITH THE PATIENT. A BOSTON SCIENTIFIC CUSTOMER REPRESENTATIVE REPORTED THE SPOUSE BLAMED THE DEVICE FOR NOT SAVING HER HUSBAND. THE AREA BOSTON SCIENTIFIC FIELD REPRESENTATIVE CONTACTED THE PATIENT'S HEALTH CARE PROVIDER; NEITHER HAD ANY ADDITIONAL INFORMATION REGARDING THE ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death 0185| 4518| N118| 1888TC