BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK FLEX LV LEAD

    MDR report key: 4192224 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04131
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 26, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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: THE REPORTED FIELD DAMAGE WAS CONFIRMED. THE APPEARANCE OF THE LEAD INDICATED THAT THE LEAD TIP AND INNER COIL WERE DAMAGED DURING THE PROCEDURE, AS REPORTED. THE FIELD COMPLAINT OF A LEAD DIAMETER ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. MAXIMUM LEAD BODY DIAMETER WAS WITHIN SPEC. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD BECAME STUCK IN A CPS SHEATH. THE LEAD WAS DAMAGED DURING AN ATTEMPT TO RETRACT THE SHEATH. LARGE LEAD DIAMETER IS SUSPECTED. LEAD WAS EXPLANTED AND RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30461 QUICK FLEX LV LEAD PERMANENT PACEMAKER ELECTRODE OJX ST. JUDE MEDICAL, CRMD 1156T/86

    Patients

    Seq Age Sex Outcome Treatment
    1