BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVA

    MDR report key: 3993118 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01921
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: 4194 LEAD, IMPLANTED (B)(6) 2010; 5554 LEAD, IMPLANTED (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE MONTHS AFTER THE IMPLANT PROCEDURE THE PATIENT SUSPECTED EARLY BATTERY DEPLETION WITH THEIR DEVICE. IT WAS FURTHER REPORTED THAT THE CLINICIAN BELIEVED THAT THE CHRONIC RIGHT VENTRICULAR AND LEFT VENTRICULAR LEADS SHOWED HIGH CAPTURE THRESHOLDS. THE DEVICE AND LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472270 BRAVA DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK IPG MFG SWITZERLAND DTBC2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 6935 LEAD