BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 4832582 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07492
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    November 9, 2014
    Report Date
    March 18, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DURING DOUBLE PACEMAKER IMPLANTING PROCEDURE, DUE TO PATIENT WITH SMALLER ATRIAL, LONG OPERATION TIME WAS ENCOUNTERED. IT WAS ALSO REPORTED THAT TWO ATRIAL LEADS ENCOUNTERED DISTORTION AND COULD NOT BE USED. THE LEADS WERE REMOVED, AND ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380322 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR