BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 3791077 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10391
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 4, 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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR A ROUTINE FOLLOW UP, IT WAS OBSERVED THAT NO SENSING OR LEAD IMPEDANCE TREND DATA WAS STORED IN THE DEVICE. ALL VALUES WERE UPDATED SUCCESSFULLY IN CLINIC. REVIEW OF THE SESSION RECORDS INDICATED THAT IMPEDANCE MEASUREMENTS HAD BEEN POSTPONED. IT WAS NOTED THAT THE PATIENT HAD SENSING AND IMPEDANCE TREND INFORMATION FROM PREVIOUS DEVICE CHECKS IN 2012. THE DIAGNOSTIC DATA WAS CLEARED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND MONITORING WILL CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268158 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3251-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR