BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3900983 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12574
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 28, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF THE DISPLAYED ERROR MESSAGE WAS CONFIRMED IN THE LABORATORY DURING INTERROGATION. UPON INTERROGATION, A PROGRAMMER ALERT INDICATED THAT THE DEVICE WAS PROGRAMMED TO EMERGENCY PACING VALUES EVEN THOUGH THE PACING MODE DISPLAYED WAS OFF. THE CAUSE OF THE FIELD EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERROGATION OF THE DEVICE SHOWED AN ALERT INDICATING THAT THE DEVICE WAS PROGRAMMED IN EMERGENCY MODE. BRADY MODE AND TACHY MODE WERE OFF. THE INTERROGATION WAS DONE BEFORE THE DEVICE WAS IMPLANTED. THE DEVICE WAS RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380521 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1