BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3181529 · Received June 21, 2013

    Report

    Report Number
    2649622-2013-08115
    Event Type
    Death
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT ID D314TRG, IMPLANTED: (B)(6) 2013; PRODUCT ID 6944-65, IMPLANTED: (B)(6) 2001; PRODUCT ID 429688, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION REQUIRING THE IMPLANTABLE CARDIAC DEFIBRILLATION (ICD) SYSTEM TO BE REMOVED. DURING THE REMOVAL OF THE ICD SYSTEM THE PHYSICIAN REPORTED THE PATIENT DIED AND THAT THE LASER LEAD EXTRACTION MAY HAVE CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282200 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death