BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVA XT

    MDR report key: 3990897 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01744
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (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 AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. DEVICE NOT AT ERI. RPE/SYSTEMS ENGINEERING SUGGESTS DEVICE IS OPERATING AS SPECIFIED. ADJUSTS LONGEVITY BASED ON PROGRAMMED SETTINGS, HOWEVER DEVICE TAKES TIME TO FULLY ADJUST LONGEVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RISING THRESHOLDS, AND LOSS OF CAPTURE WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS FURTHER REPORTED THAT RAPID BATTERY DEPLETION WAS SUSPECTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A PROCEDURE WAS SCHEDULED TO REPLACE THE RV LEAD AND ICD. THE LEAD AND DEVICE 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
    471086 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6947-65 LEAD