BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSIGNIA PLUS

    MDR report key: 1172343 · Received September 23, 2008

    Report

    Report Number
    2124215-2008-99938
    Event Type
    Death
    Date Received
    September 23, 2008
    Date of Event
    September 10, 2007
    Report Date
    September 23, 2008
    Product Code
    DXY
    Removal / Correction Number
    Z0187-94/6
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. AT THIS TIME, NO ADDITIONAL INFO IS AVAILABLE AND THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF ADDITIONAL INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM REC'D INFO THAT THE PT WITH THIS PACEMAKER DIED. A FAMILY MEMBER REPORTED THAT THIS DEVICE FAILED, HOWEVER, NO SPECIFIC PRODUCT PERFORMANCE ALLEGATIONS WERE REC'D. THE FIELD REPRESENTATIVE WAS NOT AWARE OF THIS PT OR EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA PLUS IMPLANTABLE PULSE GENERATOR DXY 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4457/473544| 4087/239563