BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2954641 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02367
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DECREASED SENSING AND DECREASED IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58212 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR