BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 2905020 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00465
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 26, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THAT THE PROXIMAL INSULATION WAS ABRADED FROM 3.1 CM - 3.7 CM FROM THE DISTAL TIP. THE REDUNDANT CONDUCTOR INSULATION WAS INTACT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTES THAT DURING A ROUTINE GENERATOR CHANGE OUT THE LEAD WAS PERFORMING NORMALLY, HOWEVER THE PHYSICIAN DECIDED TO REPLACE THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE GENERATOR CHANGE OUT DUE TO ERI, A FLUOROSCOPY REVEALED THE LEAD INSULATION WAS ABRADED. NO ELECTRICAL ANOMALIES WERE NOTED. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10949 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR