BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2053146 · Received April 13, 2011

    Report

    Report Number
    6000094-2011-00526
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 27, 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
    FS
    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED OR CONFIRMED MALFUNCTION. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE SET SCREW WAS LOOSE/DETACHED. PERFORMANCE DATA WAS ALSO ANALYZED. OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE PATIENT ALERT WAS OBSERVED ON (B)(6) 2010, AND (B)(6) 2011. THIS BEHAVIOR IS ALSO OBSERVED ON THE WEEKLY PACE LEAD IMPEDANCE TRENDS FOR THE VENTRICULAR PACE BI IMPEDANCE VALUES ON THESE DATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REPOSITIONING OF A NON-MEDTRONIC LEFT VENTRICULAR LEAD, THE PHYSICIAN WAS NOT ABLE TO FIXATE THE RIGHT VENTRICULAR LEAD CONNECTOR PIN DUE TO AN ISSUE WITH THE SET SCREW. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 Required Intervention