BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3990667 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08561
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN COULDN'T FIND A GOOD POSITION FOR THE LEAD. AFTER AN EXTENDED TIME, THE PATIENT BEGAN TO HAVE ATRIAL FIBRILLATION (AF). IT WAS DETERMINED THAT THE PATIENT WOULD NOT BE RECEIVING AN ATRIAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472733 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR