BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2951983 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00077
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 9, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    OJX
    PMA / PMN Number
    P010031/S084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY: (B)(4): PERFORMANCE DATA COLLECTED FROM THE DEVICE INDICATED PRE/APPROACHING ELECTIVE REPLACEMENT INDICATOR. THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY HAD UNEXPECTED LONGEVITY AND THE RECOMMENDED REPLACEMENT TIME (RRT) WAS REACHED BUT NO RRT WARNING WAS DISPLAYED ON THE QUICK LOOK SCREEN. 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
    56789 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO OJX IPG MFG SWITZERLAND D234TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R