BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVA XT

    MDR report key: 4121037 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17771
    Event Type
    Death
    Date Received
    September 26, 2014
    Date of Event
    August 8, 2014
    Report Date
    October 3, 2014
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    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 FROM A FUNERAL HOME WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE ONLINE OBITUARY INDICATED THE PATIENT DIED APPROXIMATELY 10 MONTHS POST IMPLANT OF THE ICD AND 9 YEARS POST IMPLANT OF THE LEADS. IT WAS REPORTED THAT THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE IS CARDIAC DYSRHYTHMIA SECONDARY TO CORONARY ARTERY DISEASE, DIABETES MELLITUS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601738 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death 419378 LEAD, 694965 LEAD, 5076-52 LEAD