BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCREW-IN

    MDR report key: 1910679 · Received November 30, 2010

    Report

    Report Number
    2649622-2010-12173
    Event Type
    Death
    Date Received
    November 30, 2010
    Date of Event
    September 15, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    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

    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 SIX MONTHS FROM REPLACEMENT IMPLANT AND DAY AFTER TISSUE VALVE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR SHORTNESS OF BREATH THIRTEEN DAYS PRIOR TO DEATH. IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH SEVERE AORTIC STENOSIS. THE PATIENT HAD AORTIC VALVE REPLACEMENT SURGERY AND "REDO STENTING" ONE DAY PRIOR TO PATIENT'S DEATH. THE PATIENT TOLERATED THE PROCEDURE WELL WITH ESTIMATED BLOOD LOSS OF 200ML. THE NEXT DAY THE PATIENT WAS CRITICALLY ILL WITH NO URINE OUTPUT AND HYPERTENSIVE. THE PATIENT UNDERWENT EXPLORATORY LAPAROSCOPY FOR ISCHEMIC BOWEL AND THE SURGERY REVEALED NO VIABLE BOWEL FOUND. THE PATIENT RETURNED TO THE INTENSIVE CARE UNIT FOR PALLIATIVE CARE AND DIED. THERE WAS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THE DEATH WAS DEVICE AND/OR LEAD RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH TWO NEW LEADS ON (B)(6) 2009 AND WAS IMPLANTED WITH A TISSUE VALVE ON (B)(6) 2009. THE PATIENT DIED ON (B)(6) 2009. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H| L| R (B)(4) TISSUE VALVE