BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 2338601 · Received September 26, 2011

    Report

    Report Number
    2338601
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE LEAD EXTRACTION FOR UPGRADE TO A BIVENTRICULAR ICS, ONE OF THE OLD PACING LEADS, PROBABLY THE RV, BROKE APART LEAVING THE PACING ELECTRODE IN THE RIGHT ATRIUM. THE EXTRACTION AND UPGRADE WERE COMPLETED WITHOUT FURTHER ISSUE. THE PT WAS BROUGHT BACK TO THE EP LAB THE NEXT DAY TO ATTEMPT TO SNARE THE LEAD TIP BY THE PHYSICIAN. AFTER SEVERAL ATTEMPTS TO SNARE THE TIP AND AFTER CONFERRING WITH INTERVENTIONAL RADIOLOGY, IT WAS DECIDED THAT IN THIS CASE LEAVING IT IN PLACE WAS THE CORRECT ACTION TO TAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL PACEMAKER LEAD DTB ST. JUDE MEDICAL, INC. 1346T158

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR