BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 3923163 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14501
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND INSULATION ABRASION AT 3.6 TO 3.9CM FROM THE DISTAL TIP. (B)(4). (B)(6).

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401871 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, INC., CRMD 1156T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1