BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 3072960 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01402
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 27, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER; PRODUCT ID NEU_ UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. THE ACTUAL EVENT DATES WERE NOT PROVIDED; THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. THE INFORMATION IN SECTION A IS THE AVERAGE FOR ALL PATIENTS. (B)(4).

    Description of Event or Problem · 1

    SUBBIAH, I. M., SUBBIAH, V., TSIMBERIDOU, A. M., NAING, A., KASEB, A., O., JAVLE, M., FU, S., HONG, D. S., PIHA-PAUL, S., WHELER, J. J., HESS, K. R., JANKU, F., FALCHOOK, G. S., WOLFF, R. A., KURZROCK, R. TARGETED THERAPY OF ADVANCED GALLBLADDER CANCER AND CHOLANGIOCARCINOMA WITH AGGRESSIVE BIOLOGY: ELICITING EARLY RESPONSE SIGNALS FROM PHASE 1 TRIALS. ONCOTARGET. 2013;4(1):153-162. SUMMARY: PATIENTS WITH ADVANCED CHOLANGIOCARCINOMA (CC) AND GALLBLADDER CARCINOMA (GC) HAVE FEW THERAPEUTIC OPTIONS FOR RELAPSED DISEASE.GIVEN THE OVERALL POOR PROGNOSIS IN THIS POPULATION AND THE AVAILABILITY OF NOVEL TARGETED THERAPIES, WE SYSTEMATICALLY ANALYZED THE CHARACTERISTICS AND OUTCOMES FOR GC AND CC PATIENTS TREATED ON PHASE I TRIALS WITH AN EMPHASIS ON TARGETED AGENTS AND LOCOREGIONAL THERAPIES. OF 40 TREATED PATIENTS (GC=6; CC=34; MEDIAN AGE, 60 YEARS), 8 (20%) HAD STABLE DISEASE (SD) > 6 MONTHS, 3 (8%) PARTIAL RESPONSE (PR), ON PROTOCOLS WITH HEPATIC ARTERIAL DRUG INFUSION AND ANTI-ANGIOGENIC, ANTI-HER-2/NEU OR NOVEL MAPK/ ERK KINASE (MEK) INHIBITORS. MEDIAN PROGRESSION-FREE SURVIVAL (PFS) ON PHASE I TRIALS WAS 2.0 MONTHS (95% CI 1.7, 2.8) VERSUS 3.0 MONTHS (95% CI 2.4,5.0), 3.0 MONTHS (95% CI 2.3, 4.6), AND 3.0 MONTHS (95% CI 2.4, 3.9) FOR THEIR FIRST-, SECOND-, AND LAST-LINE FDA-APPROVED THERAPY.IN UNIVARIATE ANALYSIS, >3 METASTATIC SITES, ELEVATED ALANINE AMINOTRANSFERASE (ALT) (>56IU/L), SERUM CREATININE (>1.6MG/DL), AND CA19-9 (>35U/ML) WERE ASSOCIATED WITH A SHORTER PFS. MUTATIONAL ANALYSIS REVEALED MUTATION IN THE KRAS ONCOGENE IN 2 OF 11 PATIENTS (18%). THE SD >6 MONTHS/PR RATE OF 28% WAS SEEN WITH HEPATIC ARTERIAL INFUSION OF OXALIPLATIN, AND INHIBITORS OF ANGIOGENESIS, HER-2/NEU OR MEK. REPORTED EVENTS: TWO PATIENTS TREATED ON DIFFERENT COMBINATION REGIMENS THAT INCLUDED AN ANGIOGENESIS INHIBITOR EXPERIENCED GRADE 3 GASTROINTESTINAL BLEEDING, PROMPTING A CHANGE OF REGIMEN, WITH OVERALL PROGRESSION-FREE PERIOD OF 10.8 AND 16.8 MONTHS, RESPECTIVELY, ON THEIR SUBSEQUENT PHASE 1 TRIALS. ONE PATIENT EXPERIENCED GRADE 3 TOXICITY THAT PROMPTED REMOVAL FROM THE STUDY DUE TO THE DEVELOPMENT OF AN ARTERIOVENOUS FISTULA DUE TO THE PLACEMENT OF THE HEPATIC ARTERIAL INFUSION CATHETER. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THROUGH FOLLOW-UP WITH THE CORRESPONDING AUTHOR IT WAS DETERMINED THAT NO MEDTRONIC PRODUCT WAS USED IN ANY OF THE PATIENTS OF CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173382 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention