BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA CRT-D

    MDR report key: 3163107 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10166
    Event Type
    Death
    Date Received
    June 11, 2013
    Date of Event
    May 9, 2013
    Report Date
    July 19, 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

    PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM A MEDICAL EXAMINER GREATER THAN TWO YEARS FROM TODAY. NO CONTACTS/EVENTS REGARDING THE SYSTEM HAVE EVER BEEN RECEIVED/REPORTED. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. PRODUCT ID: 407652, IMPLANTED: (B)(6) 2004; PRODUCT ID: 419388, IMPLANTED: (B)(6) 2004; PRODUCT ID: 694965, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS RETURNED FROM THE (B)(6) COUNTY MEDICAL EXAMINER OFFICE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY EIGHT MONTHS POST IMPLANT OF THE CRT-D SYSTEM APPROXIMATELY THREE YEARS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263619 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 00071 YR Death