BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED

    MDR report key: 2152979 · Received June 17, 2011

    Report

    Report Number
    3007566237-2011-04544
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    January 4, 2010
    Report Date
    May 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENTS, EVENTS, INTERVENTIONS AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: ALBERTS SR, ROH MS, MAHONEY MR, ET AL. ALTERNATING SYSTEMIC AND HEPATIC ARTERY INFUSION THERAPY FOR RESECTED LIVER METASTASES FROM COLORECTAL CANCER; A NORTH CENTRAL CANCER TREATMENT GROUP (NCCTG)/NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT (NSABP) PHASE II INTERGROUP TRIAL, N9945/CI-66. J CLIN ONCOL. FEB 10;28(5):853-858. SUMMARY: THE AUTHORS INDICATED THAT SURGERY FOLLOWED BY HEPATIC ARTERY INFUSION (HAI) OF FLOXURIDINE (FUDR) ALTERNATING WITH SYSTEMIC FLUOROURACIL IMPROVES SURVIVAL RATES. BETWEEN (B)(6) 2002 AND (B)(6) 2005, THE AUTHORS EXAMINED A TOTAL OF 55 ELIGIBLE PATIENTS WHO WERE ABLE TO INITIATE PROTOCOL-DIRECTED THERAPY AND COMPLETED MEDIAN OF SIX CYCLES. AN ADDITIONAL 21 PATIENTS WERE ENROLLED BUT WERE UNABLE TO BEGIN PLANNED THERAPY BECAUSE OF ELEVATED LIVER FUNCTION TESTS, DISEASE PROGRESSION, DEATHS UNRELATED TO SURGERY, BECAME INELIGIBLE OR FOR OTHER REASONS. REPORTABLE EVENT: THIRTY-TWO OF THE 55 EVALUABLE PATIENTS EXPERIENCED AT LEAST ONE GRADE 3 ADVERSE EVENTS CONSIDERED AT LEAST POSSIBLY RELATED TO STUDY TREATMENT. NO TREATMENT-RELATED FATALITIES WERE REPORTED. FOURTEEN PATIENTS EXPERIENCED A COMPLICATION RELATED TO THEIR HAI CATHETER OR PUMP; SEVEN PATIENTS EXPERIENCED CATHETER OCCLUSION, FOUR PATIENTS EXPERIENCED PUMP/CATHETER MALFUNCTION, TWO PATIENTS EXPERIENCED INFECTION AND ONE WAS UNSPECIFIED. IT WAS REPORTED THAT ONE PATIENT DIED DUE TO SURGICAL COMPLICATIONS (UNSPECIFIED) FOLLOWING PLACEMENT OF THE CATHETER BUT PRIOR TO THERAPY INITIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death IMPLANTED:| IMPLANTED:| CATHETER: MODEL CATHETER, LOT# UNK| CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED:| EXPLANTED: