BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3243953 · Received July 23, 2013

    Report

    Report Number
    2649622-2013-08251
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    May 9, 2013
    Report Date
    June 25, 2013
    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. ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ATTEMPTS WERE MADE WITH THE IMPLANTING PHYSICIAN AND THE PRIMARY PHYSICIAN AND NO ADDITIONAL INFORMATION IS AVAILABLE. CONCOMITANT PRODUCTS: 419688 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2013; N140 COMPETITOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (I CD) IMPLANTED (B)(6) 2013; 0292 COMPETITOR IMPLANTABLE TACHY LEAD IMPLANTED (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TWO WEEKS POST LEADS IMPLANT. THE CAUSE OF DEATH WAS REQUESTED AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344239 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death