BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 1223830 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03454
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMAP030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    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 ELEVATED THRESHOLDS WERE IDENTIFIED DURING A PULSE GENERATOR CHANGEOUT. THE LEADS WERE FOUND TO HAVE BEEN REVERSED. THE LEAD CONNECTIONS WERE SWITCHED TO THE CORRECT PORTS, AND NO FURTHER ANOMALIES WERE NOTED.

    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 1056T/86 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention