BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3232780 · Received July 18, 2013

    Report

    Report Number
    2649622-2013-08219
    Event Type
    Death
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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 PRODUCTS: PRODUCT ID D204TRM, IMPLANTED: (B)(6) 2013; PRODUCT ID 419688, IMPLANTED: (B)(6) 2013; PRODUCT ID 6947M55, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) AND THE TRANSMISSION REPORTED EPISODES OF VENTRICULAR RATE AT 152 BEATS PER MINUTE. THE DEVICE WAS PROGRAMMED WITH VENTRICULAR TACHYCARDIA DETECTION AT 162 BEATS PER MINUTE. THERE WERE ALSO NON-SUSTAINED VENTRICULAR EPISODES NOTED. THE CLINIC ATTEMPTED TO CALL THE PATIENT AND WHEN THERE WAS NO ANSWER A FAMILY MEMBER WAS CALLED TO CHECK ON THE PATIENT. THE PATIENT WAS FOUND TO BE DECEASED. THE CAUSE OF DEATH PER THE DEATH CERTIFICATE WAS REPORTED AS SUDDEN CARDIAC DEATH, VENTRICULAR ARRTHYMIA AND DILATED NON-ISCHEMIC CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334127 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Death