BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3881137 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02236
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 21, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO CLINIC DUE TO VIBRATORY ALERT. UPON INTERROGATION THE DEVICE WAS IN BACKUP VVI. THE DEVICE IMAGE SHOWED MULTIPLE THOR CHIP FAILURES, WHICH COULD NOT BE ASSOCIATED WITH ANY EMI SOURCES. THE DEVICE IMAGE WAS SUCCESSFULLY RELOADED ONTO THE DEVICE. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27767 UNIFY CRT-D, DF-4 CONNECTOR NIK ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD3231-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR