BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162587 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12681
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 19, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: A 5076-58 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643707 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention REDR01 IPG