BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2424189 · Received January 20, 2012

    Report

    Report Number
    3007566237-2012-00151
    Event Type
    Injury
    Date Received
    January 20, 2012
    Report Date
    December 22, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: UNK IMPLANTED: UNK EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: HOUSE, M. G., KEMENY, N., E., GONEN, M., FONG, Y., ALLEN, P. J., PATY, P. B., DEMATTEO, R. P., BLUMGART, L. H., JARNAGIN, W. R., D'ANGELICA, M. I. COMPARISON OF ADJUVANT SYSTEMIC CHEMOTHERAPY WITH OR WITHOUT HEPATIC ARTERIAL INFUSIONAL CHEMOTHERAPY AFTER HEPATIC RESECTION FOR METASTATIC COLORECTAL CANCER. ANN SURG 2011; 254: 851-856. DOI: 10.1097/SLA.0B013E31822F4F88. SUMMARY: THE AUTHORS REPORT ON THE OUTCOMES OF PATIENTS RECEIVING MODERN SYSTEMIC CHEMOTHERAPY WITH OR WITHOUT HEPATIC ARTERIAL INFUSIONAL FLOXURIDINE (HAI-FUDR) PLUS DEXAMETHASONE (DEX) FOR RESECTED LIVER-CONFINED COLORECTAL METASTASES (CRLM). BETWEEN (B)(6) 2000 AND (B)(6) 2005, 595 CONSECUTIVE PATIENTS UNDERWENT FIRST-TIME LIVER RESECTION FOR METASTATIC COLORECTAL CANCER. DURING THIS TIME, 125 PATIENTS UNDERWENT HEPATECTOMY FOR CRLM ALONG WITH PLACEMENT OF AN HEPATIC ARTERIAL INFUSION PUMP WHICH WAS USED FOR THE DELIVERY OF FUDR. THESE PATIENTS COMPRISED THE STUDY GROUP AND RECEIVED ADJUVANT SYSTEMIC CHEMOTHERAPY INCLUDING FLUOROURACIL (FU), LEUKOVORIN (LV) PLUS OXALIPLATIN OR IRINOTECAN IN ADDITION TO HAI-FUDR. THE COMPARISON GROUP INCLUDED THE MOST RECENT 125 CONSECUTIVE PATIENTS WHO UNDERWENT LIVER RESECTION AND RECEIVED ADJUVANT SYSTEMIC CHEMOTHERAPY ALONE INCLUDING FU, LV PLUS OXALIPLATIN OR IRINOTECAN. SURVIVAL ANALYSIS SUPPORTED POTENTIAL ADDED BENEFITS OF ADJUVANT HAI-FUDR/DEX AND SYSTEMIC THERAPY FOR APPROPRIATELY SELECTED PATIENTS WITH HEPATIC-ONLY COLORECTAL METASTASES. REPORTED EVENTS HAI PUMP-RELATED COMPLICATIONS INCLUDED 2 ARTERIAL PSEUDOANEURYSMS. HAI PUMP-RELATED COMPLICATIONS INCLUDED 2 GASTRIC ULCERATIONS. HAI PUMP-RELATED COMPLICATIONS INCLUDED 1 CASE OF BILIARY SCLEROSIS. FURTHER INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL NEU_UNKNOWN_CATH LOT# UNKNOWN SERIAL#