BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2791653 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15457
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 19, 2012
    Report Date
    August 1, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PHYSICIAN HAD NOTED THAT THE RA LEAD EXTRACTION WAS "EASIER". THE LAST UPDATE THE CLINICIAN HAD FOR THE PATIENT STATUS IS THAT THEY WERE STABLE. THE SYSTEM WAS EXTRACTED AND IS BEING RETAINED BY THE HOSPITAL. THE PATIENT HAD AN EMERGENCY STERNOTOMOY, CARDIOPULMONARY BYPASS WITH DEEP HYPOTHERMIC CIRCULATORY ARREST, REPAIR OF MASSIVE VENOUS INJURY, RIGHT SUBCLAVIAN TO RIGHT ATRIUM 8MM GORE-TEX BYPASS GRAFT, AND WEDGE RESECTION OF RIGHT LOWER LOBE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MASSIVE VESSEL TEAR DURING LASER LEAD EXTRACTION OF A COMPETITOR'S LEAD. THE PATIENT WAS HAVING A PROCEDURE TO REMOVE A COMPETITOR'S DEVICE AT ELECTIVE REPLACEMENT INTERVAL AND A COMPETITOR RIGHT VENTRICULAR (RV) LEAD DUE TO ADVISORY. IT WAS NOTED UPON OPENING THE POCKET THAT THERE WAS A SIGNIFICANT AMOUNT OF SCAR AND THE LEADS WERE PREPARED AND FREED DOWN TO THEIR INSERTION POINT. A STIFF STYLET WAS INTRODUCED INTO THE RIGHT ATRIAL (RA) LEAD AND THE RV LEAD WAS PREPARED FOR EXTRACTION. DURING LASER EXTRACTION OF THE RV LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED. A STERNOTOMY WAS PERFORMED AND IT WAS CONFIRMED THAT A TEAR OF THE INNOMINATE VEIN, SUPERIOR VENA CAVA AND SUBCLAVIAN VEINS HAD OCCURRED. THE PATIENT WAS LISTED AS HEMODYNAMICALLY STABLE AFTER SURGERY. DURING FOLLOW-UP WITH THE HOSPITAL IT WAS CONFIRMED THAT THE ISSUE OCCURRED DURING EXTRACTION OF THE RV LEAD AND THERE WAS NO MALFUNCTION OR ISSUE WITH THE RA LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R 1581 COMPETITOR IMPLANTABLE TACHY LEAD| V243 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB