BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA QUAD XT

    MDR report key: 3991231 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14322
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 18, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 459888, LEAD, (B)(6) 2013; 6935M62, LEAD, (B)(6) 2013. (B,(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CAPTURE MANAGEMENT FOR THE LEFT VENTRICULAR (LV) LEAD, DESPITE STABLE MEASUREMENTS, INCREASED THE PROGRAMMED AMPLITUDE, THUS REDUCING BATTERY LIFE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEFT VENTRICULAR CAPTURE MANAGEMENT (LVCM) WAS TURNED OFF AND THE DEVICE REMAINS IN USE. THE PATIENT IS ENROLLED IN (B)(4). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467472 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 00066 YR Required Intervention 4076-52 LEAD