BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREEPI

    MDR report key: 3993491 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02310
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH 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 PRODUCT: 2872 ADAPTOR, IMPLANTED: (B)(6) 2006; 4473 LEAD, IMPLANTED: (B)(6) 2005; 694965 LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT WAS TRIGGERED DUE TO THE LEFT VENTRICULAR (LV) LEAD IMPEDANCE OUT OF RANGE. THE PHYSICIAN IS CURRENTLY MONITORING THE PATIENT AND THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471974 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-60

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR D224TRK CRT-D