BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1904946 · Received November 22, 2010

    Report

    Report Number
    2647346-2010-00738
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    December 4, 2009
    Report Date
    September 18, 2019
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED FOLLOW-UP REPORT #002 SHOULD HAVE BEEN SEQUENCED #001, SO THIS REPORT IS BEING SUBMITTED AS A PLACEHOLDER WITH THE SEQUENCE #001. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS CAPPED DUE TO HIGH THRESHOLDS. THE LEAD WAS NOT REPLACED. THE DEVICE WAS REPLACED DUE TO ERI. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER REPORTED THE PATIENT DIED (B)(6) 2009 WITH UNKNOWN RELATEDNESS "TO BOTH THE SYSTEM AND AN ARRHYTHMIC EVENT." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention