BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3992173 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14893
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    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. CONCOMITANT PRODUCTS: 419478, LEAD, IMPLANTED: (B)(6) 2008; 694765, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POCKET STIMULATION FOR THE PAST TWO DAYS. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND LOW IMPEDANCES. POSSIBLE INSULATION DAMAGE IS SUSPECTED. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE HAS UNEXPECTED LONGEVITY AS THE DEVICE WAS IMPLANT JUST OVER A MONTH AGO AND THE DEVICE NOW INDICATES THE REMAINING LONGEVITY IS 1.5 YEARS. IT WAS NOTED THAT THE DEVICE HAD HIGH LV OUTPUTS. THE LV LEAD WAS REPROGRAMMED TO VERY LOW OUTPUTS FROM THE DEVICE WITH LVTIP TO RV (RIGHT VENTRICULAR) COIL CONFIGURATION AND THE POCKET/PECTORAL MUSCLE STIMULATION WENT AWAY. THE LEAD AND DEVICE 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
    468938 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 407652 LEAD