BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 4210653 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17196
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED INTERROGATION DISPLAYED MULTIPLE VENTRICULAR TACHYCARDIA EPISODES IN THE EPISODE SCREEN. HOWEVER, THESE EPISODES COULD NOT BE VIEWED PROMPTING A PROGRAMMING ERROR AND THE PROGRAMMER REBOOTS THE SYSTEM. REPROGRAMMING CHANGES WERE MADE. THE VT EPISODE SCREEN WAS ACCESSIBLE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THAT THE SAME PROBLEM HAS REOCCURED. THE DEVICE COULD NOT BE FULLY INTERROGATED DUE TO AN ONGOING EPISODE. A FIRMWARE DOWNLOAD WAS PERFORMED AND RESTORED THE NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED STATES THE STORED EGM COULD NOT BE RESTORED DUE TO LOSS OF EGMS AND MARKERS. THE DEVICE IS IN NOISE REVERSION MODE. A SOFTWARE DOWNLOAD WAS SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693603 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3213-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1