BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1980110 · Received February 7, 2011

    Report

    Report Number
    2649622-2011-00187
    Event Type
    Death
    Date Received
    February 7, 2011
    Date of Event
    August 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    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 REPORTED THAT THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER PACEMAKER IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY SEVEN MONTHS AFTER PACEMAKER IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, THE CAUSE OF DEATH IS RENAL FAILURE DUE TO MITRAL STENOSIS. NO AUTOPSY WAS PERFORMED AND THERE WERE NO ALLEGATIONS FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE AND/OR LEAD RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death (B)(4) TISSUE VALVE| (B)(4) TISSUE VALVE