BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 4160136 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02390
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    March 27, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTREONIC S.A. (SMO)
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 PRODUCTS: 6947M62 LEAD, IMPLANTED: (B)(6) 2014; A 407652 LEAD, IMPLANTED: (B)(6)2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOT CAPTURING WITHIN SEVERAL DAYS OF IMPLANT. HIGH IMPEDANCE WAS LATER OBSERVED. A CHEST X-RAY SHOWED THAT THE LEAD PIN WAS NOT FULLY INSERTED INTO THE ICD HEADER. THE POCKET WAS OPENED AND THE LEAD WAS REMOVED FROM THE HEADER WITH MINIMAL TRACTION. THE LEAD WAS THEN RE-INSERTED AND REPROGRAMMED AS LV THRESHOLD REMAINED ELEVATED. THE ICD 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
    638004 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTREONIC S.A. (SMO) DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R 5071-35 LEAD