BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO

    MDR report key: 3152386 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01233
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    October 1, 2008
    Report Date
    March 28, 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

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS WAS PERFORMED ON THE DEVICE MEMORY AND NO ANOMALIES WERE FOUND. (B)(4).

    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 THE SAME BRAND FAMILY TO A DEVICE MARKETED IN THE U.S. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INTERMITTENT HIGH RIGHT VENTRICULAR (RV) LEAD IMPEDANCE AND NOISE OBSERVED APPROXIMATELY THREE MONTHS AFTER THE DEVICE WAS REPLACED. IT WAS FURTHER REPORTED THAT THE RV LEAD WAS TESTED THROUGH THE ANALYZER AND ALL ELECTRICAL MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL RANGE AND THAT THE PHYSICIAN SUSPECTED A CONNECTION ISSUE WITH THE DEVICE. THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253007 CONCERTO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6943 IMPLANTABLE TACHY LEAD