BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2953096 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00189
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0111-2011
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT THE TIME IS APPROACHING FOR DEVICE REPLACEMENT, BUT THE DEVICE WAS NOT YET AT ELECTIVE REPLACEMENT INDICATOR (ERI). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS AT A BATTERY VOLTAGE BELOW RECOMMENDED REPLACEMENT TIME (RRT) BUT THE RRT WARNING HAD NOT YET TRIGGERED. A REVIEW OF THE DEVICE PRODUCT PERFORMANCE INFORMATION NOTED THAT THE DEVICE HAD NOT HAD THREE CONSECUTIVE RRT BATTERY VOLTAGE MEASUREMENTS WHICH ARE THE CRITERIA FOR THE RRT TRIGGER. IT WAS ALSO REPORTED THAT THE DEVICE HAD UNEXPECTED LONGEVITY OF ONLY 4 YEARS. THE DEVICE IS SCHEDULED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55630 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO LWS IPG MFG SWITZERLAND D234TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R