BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6011679 · Received October 7, 2016

    Report

    Report Number
    2649622-2016-13727
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 14, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: DTBB1Q1 ICD, IMPLANTED: (B)(6) 2016; 439888 LEAD, IMPLANTED: (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINIC RECEIVED AN ALERT TRANSMISSION AND ATTEMPTED TO CALL THE PATIENT AND WAS NOTIFIED BY A FAMILY MEMBER THAT THE PATIENT DIED EARLIER THAT DAY. CAUSE OF DEATH WAS NOT REPORTED. THE PATIENT WAS AT HOME AT THE TIME OF DEATH. EMERGENCY MEDICAL SERVICES TOLD THE PATIENT'S FAMILY THAT THE DEVICE MALFUNCTIONED. REVIEW OF THE REMOTE TRANSMISSION REVEALED THE PATIENT RECEIVED THERAPY FOR VENTRICULAR TACHYCARDIA (VT) AND THEN IT APPEARED THAT THE PATIENT WENT INTO AN AGONAL RHYTHM. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663532 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death 693565 LEAD