BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3071740 · Received April 22, 2013

    Report

    Report Number
    2182208-2013-01110
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 24, 2008
    Report Date
    January 15, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD DISLODGED. THE LEAD WAS REPLACED. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172761 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 5054

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Hospitalization| R