BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 489039 · Received October 8, 2003

    Report

    Report Number
    489039
    Event Type
    Injury
    Date Received
    October 8, 2003
    Date of Event
    August 3, 2003
    Report Date
    September 11, 2003
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO HOSP IN 2003 WITH EXACERBATION OF CHF. ON TELEMETRY, PT WAS NOTED TO HAVE PAUSES AND NON-CAPTURING OF THE PACEMAKER PORTION OF THE ICD. INTERROGATION OF DEVICE SHOWED INCREASED PACING THRESHOLD (3.0V @ 0.5MS) AND DECREASED SENSING (R-WAVE 6.6 MV), SUGGESTIVE OF VENTRICULAR LEAD DISLODGEMENT OR MALFUNCTION. A CXR WAS DONE, SHOWING WORSENING CHF AND LEAD POSITION STABLE IN THE RVA. THE MALFUNCTIONING LEAD WAS A ST. JUDE MODEL: 1570. PT WAS DISCHARGED 6 DAYS LATER, WITH A PLAN OF ANTICOAGULATION FOR FOUR WEEKS, THEN READMIT FOR A VENTRICULAR LEAD REVISION. PT TO BE SEEN IN THE OUTPATIENT CLINIC ONE MONTH LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL VENTRICULAR LEAD LWS ST JUDE MEDICAL 1570 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization