BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSITE LV

    MDR report key: 2983870 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01345
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    OJX
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z1482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. (B)(6). NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS. AN ABRASION WAS NOTED AT 3.5 CM FROM THE DISTAL END.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87454 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE OJX ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056T/75 NA

    Patients

    Seq Age Sex Outcome Treatment
    1