BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 5018245 · Received August 20, 2015

    Report

    Report Number
    2649622-2015-10603
    Event Type
    Death
    Date Received
    August 20, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 24, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT THE PATIENT'S CAUSE OF DEATH WAS DETERMINED TO BE A VF/VT ARRHYTHMIA AND THE DEATH WAS DETERMINED TO BE RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED AND DIED APPROXIMATELY 6 DAYS AFTER THE DEVICE SYSTEM WAS IMPLANTED. THE CAUSE OF DEATH WAS REPORTED TO BE AN UNVERIFIED ARRYTHMIA. THE PATIENT WAS A PARTICIPANT IN THE (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THAT THE PATIENT EXPERIENCED AN EPISODE OF PRE SYNCOPE PRE DISCHARGE POST IMPLANT, AND SUBSEQUENTLY HAD AN EPISODE OF SYNCOPE AT HOME. IT WAS ALSO REPORTED THAT AN INTERROGATION OF THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED NO VENTRICULAR FIBRILLATION (VF) OR VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THAT PER THE DEATH CERTIFICATE, THE PATIENT'S PRIMARY CASE OF DEATH IS CARDIOPULMONARY ARREST SECONDARY TO ISCHEMIC CARDIOMYOPATHY, HYPERTENSION, AND CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552307 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death