BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE FIX NOVUS

    MDR report key: 3002400 · Received March 13, 2013

    Report

    Report Number
    2649622-2013-02523
    Event Type
    Death
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 6947 IMPLANTABLE DEFIBRILLATION LEAD 2013 (B)(6). (B)(4). THE LEAD WAS NOT RETURNED AND WILL NOT BE EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CODED AND DIED AFTER THE IMPLANT OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO VENTRICULAR FIBRILLATION ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104908 CAPSURE FIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR