BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2124040 · Received June 14, 2011

    Report

    Report Number
    6000094-2011-00756
    Event Type
    Injury
    Date Received
    June 14, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE POCKET WOUND WAS VERY PAINFUL AND THE WOUND WAS REVISED. DURING THE REVISION, IT WAS NOTED THE LEAD HAD RETRACTED FROM THE ORIGINAL POSITION, AND FURTHER TESTING REVEALED LEFT ATRIAL CAPTURE RATHER THAN LEFT VENTRICULAR CAPTURE. THE LEAD COULD NOT BE REPOSITIONED INTO THE ORIGINAL POSITION DUE TO A THROMBUS OCCLUSION OF THE LEFT SUBCLAVIAN VEIN. REPLACEMENT OF THE LEAD IS PLANNED. NO FURTHER 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 S.A. D294TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R