BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA

    MDR report key: 1831645 · Received September 13, 2010

    Report

    Report Number
    2647346-2010-00520
    Event Type
    Death
    Date Received
    September 13, 2010
    Date of Event
    June 28, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. INFORMATION SUBSEQUENTLY RECEIVED ON 9/9/2010 REVEALED THE PATIENT HAD DIED. OF NOTE, THE REPORTABLE INJURY IS NORMALLY SUBMITTED VIA AN INFECTION SUMMARY REPORT THAT SHOULD HAVE BEEN DUE ON (B)(6)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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING OVERLAY BREACHED CUT. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED DUE TO INFECTION ON (B)(6) 2010. THE ORGANISM ASSOCIATED WITH THE INFECTION WAS A COAGULASE NEGATIVE (B)(6) . ANTIBIOTICS USED TO TREAT THE PATIENT WERE LINEZOILID AND CEFTRAXONE. IT WAS LATER DETERMINED THE PATIENT HAD DIED 24 DAYS LATER. FOLLOW UP REVEALED THE PATIENT HAD BEEN AT THE HOSPITAL TO HAVE BYPASS SURGERY AND VALVE REPLACEMENT WHEN THE DEVICE POCKET INFECTION WAS DISCOVERED. "PATIENT DIED (B)(6) 2010 FROM MULTISYSTEM FAILURE DUE TO SEPSIS."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE SYSTEM WAS EXPLANTED, DUE TO INFECTION ON (B)(6)2010. THE ORGANISM ASSOCIATED WITH THE INFECTION WAS COAGULASE NEGATIVE STAPH. ANTIBIOTICS USED TO TREAT THE PATIENT WERE LINEZOILID AND CEFTRAXONE. IT WAS LATER DETERMINED THE PATIENT HAD DIED 24 DAYS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA ASKU NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death