BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTRUST VR

    MDR report key: 2071173 · Received April 27, 2011

    Report

    Report Number
    6000144-2011-02054
    Event Type
    Death
    Date Received
    April 27, 2011
    Date of Event
    July 31, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEADS. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A LAWSUIT ALLEGED THAT THE LEAD WAS FRACTURED AND EXPLANTED. INFORMATION IDENTIFIED IN THE MANUFACTURE DATABASE NOTED THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D154VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death