BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4143134 · Received October 6, 2014

    Report

    Report Number
    2649622-2014-10406
    Event Type
    Death
    Date Received
    October 6, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A HOSPITAL WITH INFORMATION INDICATING THAT THE PATIENT IS DECEASED. THE DATE OF DEATH WAS NOT PROVIDED AND NO INFORMATION RELATED TO THE DEATH WAS PROVIDED. THE DEVICE SYSTEM WAS EXPLANTED APPROXIMATELY ONE MONTH POST IMPLANT. THE CAUSE OF DEATH IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624234 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death D334DRG ICD, 6935-65 LEAD