BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1922164 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05877
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    August 18, 2010
    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
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ITS ELECTIVE REPLACEMENT INDICATOR, AND HAD PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE PATIENT WAS "FILLING WITH FLUID A LITTLE BIT", AND THE PATIENT WAS PUT ON MEDICATION. THE DEVICE WAS EXPLANTED AND REPLACED. 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 CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R 6944 IMPLANTABLE TACHY LEAD| 5568 IMPLANTABLE PACING LEAD| 4968 IMPLANTABLE PACING LEAD