BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA S

    MDR report key: 3152967 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01108
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED NO ANOMALIES WERE FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE HAD HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS WHEN MEASURED THROUGH THE DEVICE. THE CONNECTION WAS CLEANED AND RECONNECTED SEVERAL TIMES, BUT THE CONFIGURATIONS BETWEEN THE ANALYZER AND THE DEVICE STILL DIFFERED. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED WHICH SHOWED THE SAME CONFIGURATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254594 VIVA S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBB2D4

    Patients

    Seq Age Sex Outcome Treatment
    1