BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 2951683 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00055
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 5, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031/S057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE U.S., HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND ANALYSIS REVEALED NORMAL DEPLETION THAT MEETS 80% OF EXPECTED LONGEVITY. THE DEVICE ACTUALLY MET 91% OF THE EXPECTED LONGEVITY. PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED THAT THERE WAS AN ALERT FOR LOW BATTERY VOLTAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD UNEXPECTED LONGEVITY. ALL THE PARAMETERS WERE STABLE AND THE PHYSICIAN WAS EXPECTING A LONGER LONGEVITY WITH THE PARAMETERS PROGRAMMED. 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
    56350 CONCERTO CRT-D DR AT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND C174AWK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R