BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 3050309 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05858
    Event Type
    Death
    Date Received
    April 10, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). CONCOMITANT PRODUCTS: 6947 IMPLANTABLE TACHY LEAD IMPLANTED (B)(6) 2004; 4193 IMPLANTABLE PACING LEAD IMPLANTED (B)(6) 2004; 5076 IMPLANTABLE PACING LEAD IMPLANTED (B)(6) 2004.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIANS OFFICE NOTED THAT THE SOURCE OF INFECTION WAS THE PATIENT'S HEART VALVE AND WAS NOT FROM THE DEVICE SYSTEM. PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS INDICATED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED WITH NO INFORMATION. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE SYSTEM WAS REMOVED DUE TO AN 'AORTIC' INFECTION AND THE PATIENT DIED POST EXPLANT DUE TO SEPSIS. THE CAUSE OF DEATH WAS NOTED AS CLINICAL SEPSIS, ENDOCARDITIS AND (B)(6). THE SOURCE OF THE INFECTION WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED WITH NO INFORMATION. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE SYSTEM WAS REMOVED DUE TO AN ¿AORTIC¿ INFECTION AND THE PATIENT DIED POST EXPLANT DUE TO SEPSIS. THE CAUSE OF DEATH WAS NOTED AS CLINICAL SEPSIS, ENDOCARDITIS AND METHICILLIN SENSITIVE STAPH AUREUS BACTEREMIA. THE SOURCE OF THE INFECTION WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153902 CONCERTO CRT-D DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO C154DWK

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death| H| R