BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF4 CONNECTOR

    MDR report key: 3915891 · Received January 15, 2014

    Report

    Report Number
    2938836-2014-06323
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    November 29, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 FEW DAYS AFTER IMPLANTABLE OF THE LV LEAD, INFECTION WAS NOTED IN THE POCKET. THE DOCTOR DECIDED TO EXPLANT THE WHOLE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39400 UNIFY CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK NIK ST. JUDE MEDICAL INC., CRMD CD3235-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention