BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 3993400 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14631
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. CONCOMITANT MEDICAL PRODUCTS: 429888 LEAD, IMPLANTED (B)(6) 2013; 5076-52 LEAD, IMPLANTED (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE SHOWED THERE WAS LESS THAN ONE MONTH OF BATTERY REMAINING, BUT THE BATTERY VOLTAGE MEASURED 2.97V AND THE DEVICES WAS NOT NEAR TO THE RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470923 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBX1QQ

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR 6935M62 LEAD