BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2964395 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00410
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 27, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME FAMILY TO A DEVICE MARKETED IN THE U.S. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. PERFORMANCE DATA WAS ALSO COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS OF THE DATA REVEALED THAT THE DEVICE WAS PRE/APPROACHING EOL/EOS/ERI/RRT. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWS THE MIN BATTERY EQUALING 2.989 TO 2.641 VOLTS BETWEEN (B)(4) 2012 AND (B)(4) 2012 WHICH IS BEFORE DEVICE RRT (RECOMMENDED REPLACEMENT TIME) OF LESS THAN OR EQUAL TO 2.6251 VOLTS.

    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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION, AS THE DEVICE ONLY LASTED TWO YEARS. THE DEVICE WAS 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
    68923 CONCERTO II CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND D294TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R