BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2883963 · Received December 21, 2012

    Report

    Report Number
    2649622-2012-18293
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PRODUCT: 6949 IMPLANTABLE DEFIBRILLATION, LEAD 2006 (B)(6). (B)(4). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER BEING SHOCKED EXTERNALLY IN THE AMBULANCE IN ROUTE TO THE HOSPITAL. THE PATIENT RECEIVED CPR AND WAS PRONOUNCED DEAD. IT WAS ALSO NOTED THAT THE PATIENT WAS RECEIVING SHOCKS AFTER BEING PRONOUNCED DEAD AND A MAGNET WAS TAPED TO THE CHEST. THE ACTUAL CAUSE OF DEATH IS UNKNOWN AND UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THE DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR