BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1242167 · Received November 13, 2008

    Report

    Report Number
    2647346-2008-00589
    Event Type
    Death
    Date Received
    November 13, 2008
    Date of Event
    January 18, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED; THE CAUSE OF DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY - PRELIMINARY TESTING REVEALED THE DEVICE HAD NO TELEMETRY AND NO PACING OUTPUT. FURTHER ANALYSIS FOUND THE BATTERY WAS DEPLETED AND WAS FULLY FUNCTIONAL WHEN POWERED EXTERNALLY. IT IS BELIEVED MOST LIKELY THE DEVICE CONTINUED TO DETECT AND CHARGE POST EXPLANT BECAUSE VF DETECTION HAD BEEN LEFT ON. DURING THE SIX MONTHS BETWEEN EXPLANT AND ANALYSIS, THE DEVICE LIKELY ACCUMULATED ENOUGH CHARGE TIME TO DEPLETE THE BATTERY. HOWEVER, BECAUSE THE BATTERY WAS DEPLETED AND ALL THE DATA WAS CLEARED FROM THE DEVICE MEMORY, THERE IS NO WAY TO BE CERTAIN THAT CHARGE TIME WAS THE CAUSE OF THE BATTERY DEPLETION.

    Description of Event or Problem · 1

    ASKU

    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 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD