BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA S

    MDR report key: 3991653 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14255
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 693558; LEAD, IMPLANTED: (B)(6) 2014; ICF09B45, LEAD, IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCONSISTENT IMPEDANCE TREND POST-UPGRADE. IT WAS DETERMINED THAT THIS RESULTED FROM A CONNECTION ISSUE BETWEEN THE RV LEAD AND THE DEVICE. THE RV LEAD WAS REVISED AND RE-ATTACHED SUCCESSFULLY. 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
    471120 VIVA S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTBB1D1

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 419378 LEAD