BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2131143 · Received June 16, 2011

    Report

    Report Number
    6000144-2011-03446
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 1, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT WAS TRIGGERED. INTERROGATION SHOWED THAT THE ALERT TRIGGERED DUE TO OUT OF RANGE (OOR) LEAD IMPEDANCES ON THE DAY OF THE IMPLANT, PRIOR TO THE LEADS BEING CONNECTED TO THE DEVICE. CURRENT IMPEDANCES WERE CONSIDERED TO BE EXCELLENT. IT WAS DEEMED TO BE NORMAL OPERATION, AND THE INTERROGATION WOULD CLEAR THE ALERT. THE DEVICE 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
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD