BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1882275 · Received October 26, 2010

    Report

    Report Number
    2649622-2010-11966
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    May 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS LAST SEEN AT THE DEVICE CLINIC FOR AN INFECTION FIFTEEN DAYS PRIOR TO THE PATIENT'S DEATH. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EXPLANT OF THE DEVICE AND LEADS AND EXPERIENCED A HEMOTHORAX DUE TO VESSEL PERFORATION AND STROKE AS A RESULT OF COMPLICATIONS RELATED TO EXPLANT PROCEDURE. THE PATIENT DIED ON (B)(6)-2010 AND THE CAUSE OF DEATH WAS REPORTED AS "STROKE AND HEMOTHORAX, RESPIRATORY FAILURE". THE PATIENT WAS PACEMAKER DEPENDANT. THERE WAS NO AUTOPSY PERFORMED AND NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE OR LEAD RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| H| L| R