BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3993266 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14656
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 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
    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 PRODUCT: MODEL: 693565, LEAD; IMPLANT: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENTS SPOUSE THAT THE BI-V IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SOUNDING AN ALERT TONE EVERY FOUR HOURS. IT WAS RECOMMENDED THAT THEY CONTACT THEIR PHYSICIAN. FOLLOW-UP WITH THE CLINIC REVEALED THE PATIENT WAS SEEN IN-OFFICE THE SAME DAY. THE HEALTHCARE PROFESSIONAL WAS UNABLE TO VERIFY WHAT THE ALERT WAS FOR, BUT DID VERIFY THE DEVICE WAS INTERROGATED AND THE ALERT WAS CLEARED. THE DEVICE AND LEADS 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
    470245 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention 407652, LEAD