BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX

    MDR report key: 1039491 · Received April 25, 2008

    Report

    Report Number
    2649622-2008-02037
    Event Type
    Death
    Date Received
    April 25, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. MODEL KDR701 IS PART OF THE ADVISORY FOR THIS MODEL. RETURN OF THE DEVICE AND LEAD HAVE BEEN REQUESTED, BUT THEY HAVE NOT BEEN RECEIVED. CAUSE OF DEATH WAS REQUESTED AND WAS REPORTED TO BE LISTED ON THE DEATH CERTIFICATE AS A) TRAUMATIC HEMOPERICARDIUM B) PERFORATION OF THE RIGHT ATRIUM C) ATTEMPTED PACEMAKER LEAD EXTRACTION D) SINUS NODE DYSFUNCTION. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. ON AUGUST 20, 2010: AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THE ATRIAL LEAD HAS BEEN ADDED TO THE EVENT. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER MALFUNCTIONED, AND THERE WAS ATRIAL AND VENTRICULAR LEAD OVERSENSING AND MALFUNCTION. DURING THE CHANGEOUT PROCEDURE, TRACTION WAS APPLIED TO THE V LEAD, BUT IT COULD NOT BE FREED FROM ITS LOCATION DUE TO SCAR TISSUE ALONG THE SUBCLAVIAN VEIN AND SVC. LASER ABLATION WAS USED ALONG THE LEAD AND NEAR THE RIGHT ATRIUM. THE PATIENT'S BLOOD PRESSURE DECREASED SUDDENLY, AND A CODE BLUE WAS CALLED. A PERICARIOCENTESIS WAS PERFORMED. ALL INTERVENTIONS FAILED, AND THE PATIENT EXPIRED. THE PRIMARY CAUSE OF DEATH WAS A TRAUMATIC HEMOPERICARDIUM, AND SECONDARY CAUSE OF DEATH WAS PERFORATION OF THE RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R 5068 IMPLANTABLE PACING LEAD