BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 4083638 · Received January 10, 2014

    Report

    Report Number
    2017865-2014-01227
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    August 6, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOSS OF CAPTURE AT MAX OUTPUT. THRESHOLD HAS BEEN PREVIOUSLY HIGH. THE PATIENT EXPERIENCED SHORTNESS OF BREATH DUE TO NO PACING. THE LEAD WILL BE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18167 QUICKSITE LV PERMANENT PACEMAKER ELCTRODE OJX ST. JUDE MEDICAL, INC. CRMD 1056T/86

    Patients

    Seq Age Sex Outcome Treatment
    1