BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA QUAD XT

    MDR report key: 3153733 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01161
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: CONCLUSION, PRODUCT EVENT SUMMARY PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A MISSING GROMMET. THE RETURNED DEVICE INDICATED A MISSING SET SCREW.

    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. PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED DEVICE SET SCREW WAS MISSING PART. THE DEVICE GROMMET WAS MISSING PART. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO BE PLACED INTO THE TARGETED VEIN. THE LEAD WAS NOT IMPLANTED AND WAS REPLACED WITH A COMPETITOR¿S LEAD. IT WAS ALSO REPORTED THAT DURING IMPLANT, THERE WAS DIFFICULTY INSERTING THE LEAD IN THE CONNECTOR. ONE THE CONNECTION WAS MADE, HIGH IMPEDANCE WAS TESTED. THE SETSCREW WAS UNSCREWED TO RE-INSERT THE LEAD, BUT IT WAS IMPOSSIBLE TO SCREW BACK IN. THE PHYSICIAN DECIDED TO USE ANOTHER DEVICE, BUT THE SAME EXACT ISSUE OCCURRED WITH THE SECOND DEVICE. BOTH DEVICES WERE NOT IMPLANTED. A COMPETITOR¿S DEVICE WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257676 VIVA QUAD XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2QQ

    Patients

    Seq Age Sex Outcome Treatment
    1