BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1971353 · Received January 27, 2011

    Report

    Report Number
    2649622-2011-00123
    Event Type
    Death
    Date Received
    January 27, 2011
    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
    AR, 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 THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SEPSIS AND RESPIRATORY FAILURE AND HAD THE ENTIRE SYSTEM (DEVICE AND TWO LEADS) REMOVED DUE TO SEPSIS ADVANCING TO PERICARDITIS. THE PATIENT'S CONDITION DID NOT IMPROVE AFTER DEVICE REMOVAL AND THE PATIENT EXPIRED 6 DAYS LATER. NO ALLEGATIONS HAVE BEEN MADE AGAINST THE DEVICE OR LEADS.

    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 65 YR Death| H| L| O| R