BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SP

    MDR report key: 2022687 · Received March 17, 2011

    Report

    Report Number
    2649622-2011-04100
    Event Type
    Death
    Date Received
    March 17, 2011
    Date of Event
    September 30, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    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

    INFORMATION OBTAINED VIA THE MANUFACTURE DATA BASE SHOWED THE PATIENT DIED SEVEN MONTHS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR. INFORMATION OBTAINED THROUGH FOLLOW UP REVEALED THE PATIENT HAD (B)(6), A PIG VALVE REPLACEMENT AND ENDOCARDITIS. THE PATIENT HAD BEEN RECEIVING HOSPICE/PALLIATIVE CARE AND WAS ADMITTED TO THE HOSPITAL NINETEEN DAYS PRIOR TO DEATH FOR MULTI-SYSTEM ORGAN FAILURE, CONGESTIVE HEART FAILURE, AND CIRRHOSIS OF THE LIVER SECONDARY TO PLATELET COUNT, AND GASTROINTESTINAL BLEED. THE PHYSICIAN CARING FOR THE PATIENT STATED THE OVERALL PROGNOSIS WAS POOR AND HE WAS DYING FROM A PRIMARY PROBLEM RELATED TO THE LIVER, LOW PLATELETS AND LOW HEMOGLOBIN. THE PHYSICIAN ALSO STATED THAT "THE PATIENT HAS A VERY SHORT TIME TO LIVE???" THE CAUSE OF DEATH WAS MULTI-SYSTEM ORGAN FAILURE SECONDARY TO (B)(6), CIRRHOSIS, LOW PLATELET COUNT, AND ANEMIA.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4524 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death