BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 3153004 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01112
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 11, 2013
    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/SIMILAR 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 NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS REVEALED THE DEVICE WAS PRE/APPROACHING RECOMMENDED REPLACEMENT TIME (RRT). THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN BAT EQUAL TO 2.974 TO 2.663 VOLTS MINIMUM BETWEEN (B)(4)-2012 AND (B)(4)-2013 IS BEFORE DEVICE RRT LESS THAN EQUAL TO 2.6251 VOLT. CONTINUATION: 4195 IMPLANTABLE PACING LEAD 2010-(B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) AND THERE WAS A CONCERN WITH THE DEVICE LONGEVITY BEING UNEXPECTED SINCE THE DEVICE HAD BEEN IMPLANTED JUST LESS THAN THREE YEARS. ALSO, THE LEFT VENTRICULAR (LV) LEAD HAD HIGH PACING THRESHOLDS AND THERE WERE PERIODS OF TIME WHEN THE LV LEAD HAD BEEN DEACTIVATED DUE TO THE THRESHOLD. THE DEVICE IS SCHEDULED TO BE EXPLANTED AND REPLACED. THE LV LEAD IS STILL 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
    255000 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D234TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R