BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1972037 · Received January 27, 2011

    Report

    Report Number
    2649622-2011-00140
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    September 28, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 7 WEEKS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEVIED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 7 WEEKS AFTER DEVICE IMPLANT. FOLLOW UP LATER REVEALED THAT PER THE DEATH CERTIFICATE, CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE DUE TO ATHEROSCLEROTIC CARDIOVASCULAR DISEASE. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 7 WEEKS AFTER DEVICE IMPLANT. FOLLOW UP LATER REVEALED THAT PER THE DEATH CERTIFICATE, CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE DUE TO ATHEROSCLEROTIC CARDIOVASCULAR DISEASE. FOLLOW UP LATER REVEALED PATIENT ADMITTED TO HOSPITAL FOR ENDSTAGE CORONARY ARTERY DISEASE WITH GRADUAL DETERIORATION. POOR RESPONSE TO DIURETICS AND EIGHT DAYS PRIOR TO DEATH, SPOUSE REQUESTED NO FURTHER AGGRESSIVE TREATMENTS. NO AUTOPSY WAS PERFORMED. IT WAS REPORTED THE DEATH WAS NOT RELATED TO 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 66 YR Death