BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVA

    MDR report key: 3858092 · Received June 9, 2014

    Report

    Report Number
    9614453-2014-01087
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 3, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 ACTUAL DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THE ANALYST NOTED THAT THERE WAS A CONFIRMED GREY GAR ON THE INTERROGATION REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEVICE INTERRAGTION, THE DEVICE SHOWED THE GREY BAR. THE DEVICE WAS NEVER IMPLANTED AND A DIFFERENT DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335715 BRAVA DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBC2D4

    Patients

    Seq Age Sex Outcome Treatment
    1