BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2101267 · Received May 24, 2011

    Report

    Report Number
    2649622-2011-07643
    Event Type
    Death
    Date Received
    May 24, 2011
    Date of Event
    March 21, 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
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED ABOUT THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, AND HAD THIS IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM IMPLANTED TO REPLACE A PREVIOUS SYSTEM. THE PATIENT EXPIRED APPROXIMATELY ONE MONTH LATER. THE EXACT DETAILS OF THE INFECTION AND CIRCUMSTANCES SURROUNDING THE DEATH HAVE BEEN REQUESTED AND NOT YET RECEIVED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN AGAINST THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION, AND HAD THIS IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM IMPLANTED TO REPLACE A PREVIOUS SYSTEM. THE PATIENT EXPIRED APPROXIMATELY (B)(6). THE EXACT DETAILS OF THE INFECTION AND CIRCUMSTANCES SURROUNDING THE DEATH HAVE BEEN REQUESTED AND NOT YET RECEIVED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN AGAINST THE DEVICE. IT HAS BEEN FURTHER REPORTED THAT THE PATIENT HAD A HEART TRANSPLANT AND THE SYSTEM WAS IMPLANTED AFTER THE TRANSPLANT. ON THE DAY OF DEATH THE PATIENT HAD MULTIPLE VENTRICULAR FIBRILATION EPISODES THAT WERE TREATED APPROPRIATELY, HOWEVER SOME ATRIAL UNDERSENSING WAS NOTED. POSSIBLE ATRIAL LEAD DISLODGEMENT WAS SUSPECTED. NO EVIDENCE SUGGESTS THAT THE DEVICE WAS RELATED TO THE DEATH.

    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 50 YR Death| H| L| O| R