BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVA XT

    MDR report key: 3991417 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01704
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: 4396 LEAD, IMPLANTED (B)(6) 2014; 6935M LEAD, IMPLANTED (B)(6) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY FOUND NO ANOMALIES. BATTERY VOLTAGE EQUALS 2.94 AS OF (B)(6) 2014.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED, INDUCING VENTRICULAR FIBRILLATION (VF) FOR WHICH THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD. THE LV LEAD WAS EXPLANTED AND REPLACED AND THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE SHOCKS UNEXPECTEDLY REDUCED THE BATTERY LONGEVITY OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHICH REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468911 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBA2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR 4076 LEAD