BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3863069 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10970
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MEDICAL PRODUCTS: A 5076-52 LEAD, IMPLANTED: (B)(6) 2004. A 5071-35 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING THE IMPLANTING PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LOST WIRELESS TELEMETRY. THE WIRELESS SIGNAL WAS LOST WHEN THE DEVICE WAS HANDED OFF TO THE STERILE FIELD AND PLACED ON THE METAL STERILE TABLE (WHICH IT USUALLY DOES). ALTHOUGH, UPON IMPLANT, THE WIRELESS SIGNAL DID NOT RETURN AS USUAL. THEY ATTEMPTED TO TURN OFF ALL DEVICES THAT HAVE BEEN KNOWN TO CAUSE INTERFERENCE: OVERHEAD LIGHTS, PHYSICIAN HEAD LAMP, AND THE PROGRAMMER WAS MOVED CLOSER TO THE DEVICE IN THE POCKET, NONE RETURNED THE WIRELESS SIGNAL. UPON PLACING THE PROGRAMMING HEAD OVER THE DEVICE THROUGH A STERILE BAG, THE SIGNAL RETURNED AND THEY WERE ABLE TO DISCONTINUE CONNECTION VIA THE PROGRAMMING HEAD. THE LIGHTS AND ALL THAT WERE TURNED OFF WERE TURNED BACK ON IN THE ROOM AND THEY CONTINUED TO HAVE WIRELESS TELEMETRY. THE DEVICE REMAINS 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
    337674 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR 694765 LEAD