BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO II CRT-D

    MDR report key: 4831589 · Received June 10, 2015

    Report

    Report Number
    9614453-2015-01189
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 14, 2015
    Report Date
    April 21, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE.

    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. (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 SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT IS TIME FOR DEVICE REPLACEMENT. ANALYST COMMENTED, TIME OF RECOMMENDED REPLACEMENT TIME (RRT): (B)(4) 2015 02:15:00.

    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 MULTIPLE PATIENT ALERTS TRIGGERED DUE TO IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LOW BATTERY VOLTAGE. THE ICD INDICATED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). THE ICD REMAINS IN USE AND DEVICE REPLACEMENT WAS RECOMMENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376686 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D294TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR