BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3861757 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11157
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT PRODUCTS: 419688 LEAD, IMPLANTED: (B)(6) 2011; A 559445 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE IS SUSPECTED OF EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. HOWEVER, POST GENERATOR CHANGE PROCEDURE THE LEFT VENTRICULAR (LV) LEAD WAS READING HIGH IMPEDANCE. THE POCKET WAS REOPENED AND IT WAS FOUND THAT THE SETSCREW ON THE HEADER OF THE DEVICE FOR THE LV LEAD WAS LOOSE. THE SETSCREW WAS TIGHTENED AND THE ISSUE WAS RESOLVED. THE REPLACEMENT DEVICE AND LV LEAD REMAIN 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
    341903 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 Hospitalization| R 6944-58 LEAD