BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3891176 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03576
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    February 14, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    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 REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE CHECK THE PROGRAMMED VECTORS SEEMED TO HAVE CHANGED. REVIEW OF THE SESSIONS RECORDS SHOED THE PROGRAMMING WAS FROM DATE OF IMPLANT AND NO CHANGES HAD BEEN MADE. WITHOUT REVIEW OF THE SESSION RECORDS, NO FURTHER INFORMATION COULD BE PROVIDED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31178 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFRIBILLATOR, NIK NIK ST. JUDE MEDICAL, INC., CRMD CD3235-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1