BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1844616 · Received September 27, 2010

    Report

    Report Number
    2649622-2010-09052
    Event Type
    Death
    Date Received
    September 27, 2010
    Date of Event
    July 18, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. INFORMATION SUBSEQUENTLY RECEIVED ON 9/24/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE MALFUNCTION IS NORMALLY SUBMITTED VIA A (B)(4) MEDWATCH REPORT SUBMISSION THAT WOULD HAVE BEEN DUE ON 10/10/2010. HOWEVER, AS THERE IS NOW INFORMATION THAT REASONABLY SUGGESTS THAT THE DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH, THIS NOW REQUIRES SUBMISSION AS A 30-DAY REPORT.

    Additional Manufacturer Narrative · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN IN THE CLINIC AND IT WAS NOTED THE SVC IMPEDANCE WAS GREATER THAN 200 OHMS. THE PATIENT HAD AN ELEVATED WHITE BLOOD COUNT, "SO THE DR. DOES NOT WANT TO TAKE HIM TO THE OR." LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY 2 WEEKS LATER. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SEEN IN THE CLINIC AND IT WAS NOTED THE SVC WAS GREATER THAN 200 OHMS. THE PATIENT HAD AN ELEVATED WHITE BLOOD COUNT, "SO THE DR. DOES NOT WANT TO TAKE HIM TO THE OR." LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED APPROXIMATELY 2 WEEKS LATER. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP REVEALED PATIENT LAST SEEN IN CLINIC APPROXIMATELY 3 YEARS PRIOR TO DEATH AND WAS NOTED TO BE NONCOMPLIANT. THE PATIENT WAS HOSPITALIZED THE WEEK BEFORE HIS DEATH AND DIAGNOSED WITH DIABETES/HYPOGLYCEMIA, SEPSIS WITH RESPIRATORY FAILURE, AND METABOLIC ENCEPHALOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death