BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 4182211 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04202
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    November 5, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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: ANALYSIS WAS NORMAL. VISUAL INSPECTION OF THE LEAD FOUND THE OUTER INSULATION AND THE INNER COILED WERE DAMAGED AT SEVERAL LOCATIONS. THE DAMAGES FOUND ON THE LEAD ARE CONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED DIAPHRAGMATIC STIMULATION AND LOSS OF CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25798 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE NIK ST. JUDE MEDICAL, INC., CRMD 1258T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention