BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSITE LV

    MDR report key: 780178 · Received November 10, 2006

    Report

    Report Number
    2017865-2006-01804
    Event Type
    Injury
    Date Received
    November 10, 2006
    Date of Event
    July 20, 2006
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS PROGRAMMED TO 5.0 V, 1.0 MS TO PROVIDE A SAFETY MARGIN TO 3.0 V, 1.5 MS CAPTURE THREHOLDS ON THE LEFT VENTRICULAR LEAD. AFTER LEAVING THE CLINIC, THE PATIENT DEVELOPED PHRENIC NERVE STIMULATION. THE DEVICE WAS PROGRAMMED TP 4.0 V, 1.5 MS WITH AN AV/PV DELAY CHANGE FROM 130/120 TO 300/275. THIS RESULTED IN A TEMPORARY STATE OF NO BI-VENTRICULAR PACING. THE LEAD WAS LATER REPOSITIONED.

    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 63 YR Required Intervention