BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 2955598 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00371
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 21, 2012
    Report Date
    December 7, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2007, 4965 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THERE WAS INTERMITTENT UNDER SENSING NOTED ON THE ATRIAL LEAD IN THE STORED DIAGNOSTICS. PROGRAMMING OPTIONS FOR THE LEAD WERE DISCUSSED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59795 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR