BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3925351 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08932
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    June 26, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED AND DID NOT CAPTURE DURING THE THRESHOLD TEST. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38302 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC. CRMD 1156T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention