BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSULTA CRT-D

    MDR report key: 3860799 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10513
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    October 1, 2013
    Report Date
    March 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0111-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THIS DEVICE WAS INCLUDED IN THE FIELD ACTION BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. CONCOMITANT PRODUCTS: 4592-45, IMPLANTABLE PACING LEAD, (B)(6) 2003; 4193-88, IMPLANTABLE PACING LEAD, (B)(6) 2003; 6984M, ADAPTOR, (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV CAPTURE MANAGEMENT TRENDS STOPPED APPROXIMATELY SIX MONTHS AGO AND THE R-WAVE TRENDS STOPPED APPROXIMATELY ONE MONTH AGO. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO A LEAD REVISION PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337956 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR 6949 IMPLANTABLE TACHY LEAD