BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 2162732 · Received July 14, 2011

    Report

    Report Number
    2647346-2011-00943
    Event Type
    Death
    Date Received
    July 14, 2011
    Date of Event
    February 5, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. (B)(4): THE PROXIMAL SECTION OF THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    THE IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM WAS RETURNED WITH NO INFORMATION. A DATABASE SEARCH BY SERIAL NUMBER REVEALED THE PATIENT HAD EXPIRED 2 YEARS AGO. THE DEATH OCCURED LESS THAN ONE YEAR AFTER IMPLANT OF THE DEVICE. NO PREVIOUS CONTACTS, COMPLAINTS, OR ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE SYSTEM OR ANY OF IT'S INDIVIDUAL COMPONENTS.

    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 71 YR Death| O