BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST JUDE MEDICAL LEAD

    MDR report key: 1036044 · Received April 23, 2008

    Report

    Report Number
    1036044
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 29, 2008
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CAME TO CATH LAB FOR REMOVAL OF PACEMAKER PULSE GENERATOR; REMOVAL OF ATRIAL AND VENTRICULAR LEADS DUE TO PACEMAKER BATTERY DEPLETION AND LEAD REVISION DUE TO EXIT BLOCK ON HER ATRIAL LEAD. DURING THE PROCESS OF REMOVING LEADS, THE DISTAL ATRIAL ELECTRODE FRACTURED AND BECAME IMBEDDED IN DISTAL RIGHT PULMONARY ARTERY. ATTEMPT AT SNARING FRAGMENT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL LEAD PACEMAKER ATRIAL LEAD DTB ST. JUDE MEDICAL, INC. 1488T/52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other 58CM, NC54243| EXPLANTED VENTRICULAR LEAD WAS ST JUDE, 1480AT| EXPLANTED PACEMAKER WAS A ST JUDE MEDICAL| MODEL # 5380