BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT PACEMAKER LEADWIRE

    MDR report key: 18803 · Received October 18, 1994

    Report

    Report Number
    18803
    Event Type
    Injury
    Date Received
    October 18, 1994
    Date of Event
    September 26, 1994
    Report Date
    October 18, 1994
    Manufacturer
    SIEMENS-PACESETTER, INC.
    Product Code
    DXX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED 9/16 FOR PACEMAKER PLACEMENT DUE TO ATRIOVENTRICULAR NODE DYSFUNCTION. PULSE GENERATOR IMPLANTED. RIGHT ATRIUM LEAD AND RIGHT VENTRICLE LEAD INSERTED THROUGH LEFT SUBCLAVIAN VEIN INTO APPROPRIATE CHAMBERS AND SCREWED INTO PLACE. CHEST X-RAY AFTER PROCEDURE SHOWED NO ACTIVE INFILTRATES OR EFFUSIONS. ON 9/18, PT ADMITTED TO ER FOR CHEST PAIN DUE TO PERICARDIAL EFFUSION. ETIOLOGY OF PERICARDIAL EFFUSION NOT CLEAR, SUSPECT HAS TO DO WITH TRAUMA OF PLACING ONE OF THE PACING WIRES. THIS INCLUDES PERFORATION WHICH HAS SINCE HEALED OR MYOCARDIAL CONTUSION WITH INFLAMMATORY RESPONSE. ON 9/26, TEE IN CATH LAB FOR LARGE CIRCUMFERENTIAL PERICARDIAL EFFUSION. ECHO SUGGESTS TAMPONADE. PERICARDIOCENTESIS PERFORMED WITH PIGTAIL CATHETER IN PERICARDIAL SPACE, 210 CC REMOVED, AND SUCCESSFUL REVERSAL OF TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT PACEMAKER LEADWIRE Implant DXX SIEMENS-PACESETTER, INC. 11885/46, 1146T/52

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization