BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 1548612 · Received November 24, 2009

    Report

    Report Number
    3007566237-2009-08724
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Date of Event
    September 14, 2009
    Report Date
    October 27, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    LITERATURE: TSE AN, WU N, PATEL D, HAVILAND D, KEMENY N. A PHASE I STUDY OF GEMCITABINE GIVEN VIA INTRAHEPATIC PUMP FOR PRIMARY OR METASTATIC HEPTIC MALIGNANCIES. CANCER CHEMOTHER PHARMACOL. 2009; 64(5):935-44. SUMMARY: THIS ARTICLE PRESENTS AN OPEN-LABELED, NONRANDOMIZED PHASE I DRUG STUDY TO DETERMINE THE MAXIMUM TOLERATED DOSE AND DURATION OF HEPATIC ARTERIAL INFUSION (HAI) GEMCITABINE WITH PATIENT WITH UNRESECTABLE HEPATIC METASTASES FROM COLORECTAL CANCER OR PRIMARY HEPATIC MALIGNANCIES VIA THE SIDE-PORT OF AN IMPLANTABLE HAI PUMP FOR THREE WEEKS USING AN EXTERNAL INFUSION SYSTEM. TWENTY-EIGHT PATIENTS WERE EVALUABLE FOR TOXICITY AND RESPONSE. REPORTABLE EVENT: ONE PATIENT EXPERIENCED ABDOMINAL PAIN UPON USE OF THE HAI PUMP DURING CYCLE 4. A DIAGNOSTIC ARTERIOGRAM OBTAINED AFTER INJECTION OF CONTRAST INTO THE PUMP RESERVOIR REVEALED DISSECTION FROM THE TIP OF THE PUMP CATHETER TO THE RIGHT HEPATIC ARTERY STUMP AND COMMON HEPATIC ARTERY WITHOUT EXTRAVASATION OF CONTRAST. THE PATIENT WAS REMOVED FROM THE STUDY.

    Devices

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

    Patients

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