BEUDAMED
    FDA Adverse Event Summary report: N

    QUICKFLEX MICRO LV LEAD

    MDR report key: 4182212 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04200
    Date Received
    January 13, 2014
    Date of Event
    October 29, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    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: THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OBSERVED NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26186 QUICKFLEX MICRO LV LEAD PERMANENT PACEMAKER ELECTRODE, NIK NIK ST. JUDE MEDICAL, INC., CRMD 1258T/86

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention