BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 2131858 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01265
    Event Type
    Injury
    Date Received
    June 16, 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
    CA
    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. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED AND ANALYSIS FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS. 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.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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 AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. C174AWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R