BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 1223893 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03407
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 18, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT PRE-DISCHARGE FOLLOW-UP ONE DAY POST IMPLANT, LOSS OF CAPTURE WAS NOTED AT MAXIMUM OUTPUT. AN X-RAY CONFIRMED LEAD DISLODGEMENT AND THE LEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSITE LV PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1056K/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention