BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX XL LV LEAD

    MDR report key: 4191837 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04328
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 1, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    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. THE LEAD WAS RECEIVED IN 2 PARTS. ANALYSES WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH IMPEDANCE. IT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28293 QUICKFLEX XL LV LEAD PERMANENT PACEMAKER ELECTRODE, NIK NIK ST. JUDE MEDICAL, INC., CRMD 1158T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention