BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 2083621 · Received May 10, 2011

    Report

    Report Number
    6000094-2011-00671
    Event Type
    Death
    Date Received
    May 10, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THIS EVENT OCCURRED OUTSIDE THE U.S. 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.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND LEAD WERE RETURNED FROM A HOSPITAL INDICATING THE SYSTEM WAS EXPLANTED AFTER THE PATIENT HAD DIED. NO FURTHER INFORMATION WAS PROVIDED. 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 AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. C174AWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death COMPETITOR IMPLANTABLE PACING LEAD