BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA S

    MDR report key: 3992898 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14730
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 20, 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
    MN, 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 MEDICAL PRODUCTS: 419588, LEAD, IMPLANTED: (B)(6) 2013; 5076-52, LEAD, (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BURNING AND STINGING IN THE PATIENT'S POCKET WENT AWAY WHEN THE LEFT VENTRICULAR (LV) LEAD OUTPUT THRESHOLDS WERE TURNED DOWN. POSSIBLE DEVICE GROMMET DAMAGE WITH FLUID INGRESS TO THE SETSCREW AND AN LV LEAD INSULATION BREACH WAS DISCUSSED. IT WAS ALSO REPORTED THAT THE LV LEAD PACING IMPEDANCE HAD DROPPED TO A LOW VALUE DURING THE TIME THAT THE BURNING AND STINGING STARTED. THE DEVICE AND LV LEAD 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
    468699 VIVA S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention 694765, LEAD