BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3860477 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10555
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 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
    CA, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A LOOSE/DETACHED SET SCREW. CONCOMITANT PRODUCTS: 5076-52, LEAD, IMPLANTED: (B)(6) 2008; 5867-3M, ADAPTOR, IMPLANTED: (B)(6) 2014; 429688, LEAD, (B)(6) 2014; 5592-45, LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE FOLLOW UP THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NO CAPTURE, AND X-RAY REVEALED THAT THE LEAD HAD PULLED BACK, DISLODGED FROM ITS ORIGINAL POSITION. THE LV LEAD WAS EXPLANTED AND REPLACED. DURING THE LV LEAD REVISION THE RIGHT VENTRICULAR (RV) LEAD WAS DISCONNECTED FROM THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) FOR TESTING. UPON RECONNECT THE RV LEAD WAS UNABLE TO REINSERT INTO THE HEADER OF THE ICD, THE SET SCREW WAS NOT PROPERLY SEEDED IN THE GROMMET. AS A RESULT THE ICD WAS EXPLANTED AND REPLACED. THE RV LEAD 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
    339759 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 6947M62 LEAD