BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2952406 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01733
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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 MEDICAL PRODUCTS: 4574, IMPLANTABLE PACING LEAD, (B)(6) 2011; 4194, IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RELATIVE CALLED TO REPORT THE DEVICE BATTERY WAS VERY LOW AND HAD FEW MONTHS LEFT. FOLLOW UP CONFIRMED THAT THE PATIENT WAS BEING MONITORED CLOSELY FOR DEVICE BATTERY LIFE. IT WAS NOTED THAT THERE WAS HIGH THRESHOLDS ON ALL THREE OF THE PATIENT'S LEADS AND THE DEVICE HAD DRAMATICALLY DECREASED IN VOLTAGE. THE CUSTOMER SUSPECTS A LEAD EXIT BLOCK RELATING TO THIS ISSUE. THE DEVICE AND LEADS REMAIN 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
    57648 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D274TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR 6947 IMPLANTABLE TACHY LEAD