BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3931653 · Received July 14, 2014

    Report

    Report Number
    3008973940-2014-00233
    Event Type
    Death
    Date Received
    July 14, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT ID: 6935M62, IMPLANTED: (B)(6) 2014; PRODUCT ID: UNK-COMP-LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY WITH CARDIAC ARREST AND PULSELESS ELECTRICAL ACTIVITY. IT WAS NOTED THAT AFTER THE ADMINISTRATION OF MEDICATION, CARDIOPULMONARY RESUSCITATION AND MECHANICAL VENTILATION THE PATIENT DIED. THE PATIENT WAS A PARTICIPANT OF THE (B)(6) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410890 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Death DTBA2QQ ICD