BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCELLENCE+

    MDR report key: 1931093 · Received December 17, 2010

    Report

    Report Number
    2649622-2010-15332
    Event Type
    Death
    Date Received
    December 17, 2010
    Date of Event
    June 25, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S24
    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.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 37 DAYS FOLLOWING DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED 37 DAYS FOLLOWING DEVICE IMPLANT. FOLLOW UP LATER REVEALED PATIENT ADMITTED TO HOSPITAL 13 DAYS PRIOR TO DEATH AFTER PROGRESSIVE DECLINE IN MENTAL STATUS. BLOOD SUGARS WERE STABILIZED AND RECEIVED PARACENTESIS FOR ASCITES. PATIENT WAS DISCHARGED TO HOSPICE CARE WHERE SHE DIED THREE DAYS LATER. FINAL DISCHARGE DIAGNOSIS ON THIS PATIENT WAS HEPATIC ENCEPHALOPATHY ASSOCIATED WITH END-STAGE HEPATIC CIRRHOSIS WITH RECURRENT ASCITES. THERE IS NO ALLEGATION OF DEVICE/LEAD SYSTEM PERFORMANCE CONCERNS IN RELATIONSHIP TO HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELLENCE+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMD49JB ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| R