BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA S

    MDR report key: 3864750 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11363
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    January 3, 2014
    Report Date
    April 20, 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
    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: PRODUCT ID 6949-65, LEAD, IMPLANTED: (B)(6) 2005; PRODUCT ID 5076-52, LEAD, IMPLANTED (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MOVED AND IS MORE VISIBLE THAN THE PREVIOUS DEVICE. THE PATIENT NOTED THAT IT HURT TO LIE ON THE SIDE. 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
    337793 VIVA S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR 4194-88 LEAD