BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVA XT

    MDR report key: 6171380 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26368
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169007246
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 4195 LEAD, IMPLANTED (B)(6) 2012. 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.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT'S CAUSE OF DEATH WAS ADVANCED CARDIOMYOPATHY. THE SYSTEM WAS BELIEVED TO BE FUNCTIONING NORMALLY AND WAS NOT BELIEVED TO BE RELATED TO THE PATIENT'S DEATH IN ANY WAY.

    Description of Event or Problem · 1

    THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT HAD PASSED AWAY. THE PATIENT WAS REPORTEDLY OVER-TIRED PRIOR TO PASSING AND THE SPOUSE FELT THAT THE DEVICE SYSTEM CONTRIBUTED TO THE DEATH. FOLLOW UP YIELDED NO FURTHER INFORMATION. THE SYSTEM WAS NOT REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821603 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D1 00643169007246

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death 1688TC LEAD, 1581 LEAD