BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 4191834 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04133
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    January 7, 2013
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    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. EVAL DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28278 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, CRMD 1156T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention