BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4906486 · Received July 10, 2015

    Report

    Report Number
    2649622-2015-07753
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT MEDICAL PRODUCTS: 7122-60, ST JUDE LEAD, IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    A REPORT OF A PATIENT DEATH WAS RECEIVED WITH A CAUSE OF DEATH OF SEPTIC SHOCK PROVIDED. THE SOURCE OF THE SEPTIC SHOCK HAS BEEN REQUESTED AND NOT RECEIVED. THE PATIENT WAS A PARTICIPANT IN THE (B)(4) STUDY.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN WITH ACUTE ON CHRONIC HEART FAILURE POSSIBLY TACHY INDUCED CARDIOGENIC SHOCK PRECIPITATED BY THE SEPTIC SHOCK. THE PATIENT REQUIRED PRESSOR SUPPORT, INTUBATION AND BROAD SPECTRUM ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449343 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death