BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 4834290 · Received June 10, 2015

    Report

    Report Number
    3004209178-2015-11098
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 11, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS AND NO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT DURING THE RA LEAD REPLACEMENT, THE NEW RA LEAD DISLODGED DURING THE IMPLANT PROCEDURE. THIS RA LEAD WAS REPOSITIONED AND REMAINS IN USE. IT WAS FURTHER REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE, THE BATTERY BAR WAS GRAY WITH PRE-IMPLANT INDICATION ON THREE IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. THESE THREE DEVICES WERE NOT IMPLANTED AND AN ADDITIONAL DEVICE WAS OBTAINED AND IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378825 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR