BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1914578 · Received December 3, 2010

    Report

    Report Number
    2649622-2010-12229
    Event Type
    Death
    Date Received
    December 3, 2010
    Date of Event
    January 16, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S46
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. 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. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 10 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED 10 MONTHS AFTER DEVICE IMPLANT. FOLLOW UP LATER REVEALED THE CAUSE OF DEATH WAS SEPSIS DUE TO PNEUMONIA DUE TO URINARY TRACT INFECTION. DEATH CERTIFICATE ALSO NOTED OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH INCLUDED SEPTIC SHOCK. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5594 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death