BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1562423 · Received November 25, 2009

    Report

    Report Number
    3007566237-2009-08732
    Event Type
    Injury
    Date Received
    November 25, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 28, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: KATO Y, MATSUBARA K, AKIYAMA Y, ET AL. CHEMOTHERAPY-INDUCED SCLEROSING CHOLANGITIS AS A RARE INDICATION FOR RESECTION: REPORT OF A CASE. SURG TODAY. 2009; 39(10): 905-8. SUMMARY: THIS ARTICLE PRESENTS A CASE REPORT OF A RARE CASE OF CHEMOTHERAPY-INDUCED SCLEROSING CHOLANGITIS (CISC)-RELATED BILIARY STRICTURE REQUIRING RESECTION IN A PT RECEIVING ADJUVANT HEPATIC ARTERIAL INFUSION CHEMOTHERAPY (HAIC) WITH 5-FLUOROURACIL PLUS CISPLATIN. REPORTABLE EVENT: 11 MONTHS AFTER STATING HAIC, THE PT BEGAN TO EXPERIENCE INTERMITTENT PRURITUS AND FEVER WITH DARK URINE AND CONCOMITANT ABNORMAL LIVER FUNCTION TESTS. COMPUTED TOMOGRAPHY SHOWED NO EVIDENCE OF CANCER RECURRENCE AND DYNAMIC CT REVEALED SATISFACTORY HEPATIC ARTERIAL FLOW FROM THE LEFT HEPATIC ARTERY. MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY (MRCP) DEMONSTRATED A LIMITED BUT SEVERE STRICTURE IN THE COMMON BILE DUCT. ENDOSCOPIC BITE CYTOLOGY AND BIOPSY REVEALED NO EVIDENCE OF MALIGNANCY. THERE WAS NO APPARENT DISPOSING CONDITION. HAIC WAS DISCONTINUED AND THE PT WAS STARTED ON INTRAVENOUS AND THEN ORAL DEXAMETHASONE. THE TREATMENT ALLEVIATED THE CLINICAL SYMPTOMS, AND LIVER DYSFUNCTION TEMPORARILY, BUT THE PT RELAPSED WITH DOSE REDUCTION FOR CESSATION OF THE DRUG. AFTER THREE MONTHS OF STEROID THERAPY, THE PT UNDERWENT A SECOND MRCP WHICH SHOWED AN INTRACTABLE BUT LOCALIZED COMMON HEPATIC DUCT STRICTURE. ENDOSCOPIC BILIARY STENTING WAS TECHNICALLY DIFFICULT BECAUSE OF THE SEVERE COMMON HEPATIC DUCT SCLEROSIS. THE BILIARY STRICTURE WAS SURGICALLY RESECTED. THE PT HAD AN UNEVENTFUL COURSE AND WAS DISCHARGED WITH NORMAL LIVER FUNCTION. POSTOPERATIVELY, THE PT HAD NORMAL LIVER FUNCTION WITHOUT ANY FURTHER ISSUES OF CHOLANGITIS FOR 12 MONTHS. THE PT WAS FREE OF CANCER RECURRENCE FOR 32 MONTHS, SINCE THE PRIMARY SURGERY.

    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 64 YR Required Intervention CATHETER: MODEL UNK, LOT# UNK| IMPLANTED:| EXPLANTED: