BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3860766 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01156
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED THE SET SCREW WAS FOUND IN THE CONNECTOR BORE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  IMPLANT PROCEDURE, THE RIGHT VENTRICLE(RV) COIL PIN WAS INSERTED INTO RV PACE/SENSE PORT BY MISTAKE. AFTER THE SETSCREW WAS TIGHTENED, THE PHYSICIAN REALIZED THE MISTAKE AND LOOSENED THE SCREW TO REMOVE THE LEAD. WHEN THE RV PACE/SENSE LEAD WAS INSERTED CORRECTLY AND THE SCREW WAS ROTATED CLOCKWISE, THE SCREW WOULDN¿T MOVE. THE SCREW WAS ATTEMPTED TO BE LOOSENED, BUT THE TORQUE WRENCH WOULDN¿T MOVE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337943 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2D1

    Patients

    Seq Age Sex Outcome Treatment
    1