BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3861846 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11122
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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: 6947M-62 LEAD, IMPLANTED: (B)(6) 2014; 5076-52 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, HIGH IMPEDANCE WAS MEASURED ON THE LEFT VENTRICULAR LEAD IN ONE CONFIGURATION. A DIFFERENT CONFIGURATION "MEASURED NORMALLY WITH A GOOD THRESHOLD." THE LEAD WAS LEFT IN THE CONFIGURATION THAT "MEASURED NORMALLY." IT IS SUSPECTED THAT THERE MAY BE AN ISSUE WITH THE LEAD NOT BEING FULLY INSERTED. 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
    339715 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR 4296-88 LEAD