BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA CRT-D

    MDR report key: 3141425 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08509
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    October 1, 2012
    Report Date
    July 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 DEVICES ASSOCIATED WITH THIS ADVERSE OUTCOME WERE RETURNED AND THE PATIENT WAS IDENTIFIED AS BEING DECEASED. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. HOWEVER, IF ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESSED AND CONSIDERED ACCORDINGLY. (B)(4). CONCOMITANT PRODUCTS: 5568-45 IMPLANTABLE PACING LEAD IMPLANTED: 2007-02-22; 419378 IMPLANTABLE PACING LEAD IMPLANTED: (B)(6) 2003; 6944-65 IMPLANTABLE TACHY LEAD IMPLANTED: (B)(6) 2003.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO ADDITIONAL INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY FOUR MONTHS POST ICD IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245413 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death