BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1902631 · Received November 18, 2010

    Report

    Report Number
    6000144-2010-05608
    Event Type
    Death
    Date Received
    November 18, 2010
    Date of Event
    January 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS OF THE DEVICE FOUND A HIGH CURRENT DRAIN CONDITION. ELECTRICAL ANALYSIS REVEALED THE CAUSE OF THE HIGH CURRENT DRAIN WAS CURRENT LEAKAGE IN THE BATTERY FILTER CAPACITORS.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2010: IT WAS LATER DISCOVERED IN THE MANUFACTURER'S DATABASE THE PATIENT DIED EIGHTEEN DAYS AFTER REPLACEMENT. FOLLOW UP LATER REVEALED PATIENT HAD NOT BEEN PACEMAKER DEPENDANT. HAD BEEN ADMITTED TO CORONARY CARE UNIT 3 DAYS PRIOR TO DEATH WITH INCREASING DYSPNEA, DEHYDRATION AND POSSIBLE PNEUMONIA, NO FEVER, WEAKNESS, SLIGHTLY HYPOTENSIVE AND HYPOXIC. ECHO SHOWED DRAMATIC LV (LEFT VENTRICULAR) DYSFUNCTION, PATIENT HAD ELEVATED LIVER FUNCTION TESTS AND WAS IN ACUTE RENAL FAILURE. PATIENT WAS NOTED TO HAVE HAD A DO NOT RESUSCITATE STATUS. THERE IS NO ALLEGATION BY THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS LATER DISCOVERED IN THE MANUFACTURER'S DATABASE THE PATIENT DIED EIGHTEEN DAYS AFTER REPLACEMENT. THE 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 IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| H| L| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD