BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2794887 · Received October 17, 2012

    Report

    Report Number
    3004209178-2012-09270
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    March 9, 2011
    Report Date
    October 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), PRODUCT TYPE CATHETER. THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION.

    Description of Event or Problem · 1

    LIN, C-P., LIN, W-Y., LIN, F-S., LEE, Y-S., JENG, C-S., SUN, W-Z. EFFICACY OF INTRATHECAL DRUG DELIVERY SYSTEM FOR REFRACTORY CANCER PAIN PATIENTS: A SINGLE TERTIARY MEDICAL CENTER EXPERIENCE. JOURNAL OF THE FORMOSAN MEDICAL ASSOCIATION. 2012;111(5):253-257. BETWEEN 10% AND 20% OF CANCER PAIN PATIENTS FAIL TO OBTAIN ADEQUATE PAIN RELIEF DESPITE COMPREHENSIVE MEDICAL MANAGEMENT. THE TOTALLY IMPLANTABLE PROGRAMMABLE INTRATHECAL DRUG DELIVERY SYSTEM (IDDS) IS AN ATTRACTIVE OPTION FOR MANAGING REFRACTORY CANCER PAIN. IN SUITABLE PATIENTS, IDDS CAN PROVIDE RELIABLE LONG-TERM ANALGESIA WITHOUT ANY PERMANENT NERVE OR PLEXUS DESTRUCTION. IDDS CAN ALSO ALLOW PATIENT CARE ON AN OUTPATIENT BASIS. IN (B)(6), HOWEVER, THE EXPERIENCE OF USING IDDS IN TERMINALLY ILL CANCER PATIENTS IS VERY LIMITED. THIS RETROSPECTIVE STUDY, DESCRIBES EXPERIENCE OF MANAGING TOTALLY IMPLANTABLE PROGRAMMABLE IDDS IN 6 REFRACTORY CANCER PAIN PATIENTS INCLUDING PATIENT SELECTION, INTRASPINAL MORPHINE TRIAL, SURGICAL TECHNIQUES, COMPLICATIONS, AND DRUG ADJUSTMENT. PAIN SCORES AND FUNCTIONAL STATUS WERE COMPARED BEFORE AND AFTER IDDS. BY DELIVERING LIBERAL DOSE OF INTRATHECAL MORPHINE, PATIENTS' PAIN SCORES DECREASED FROM 10 TO 3.5. DUE TO MUCH BETTER PAIN CONTROL AND IMPROVED QUALITY OF LIFE, EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS ALSO IMPROVED IN 4/6 PATIENTS. DURING THE MEAN 5 +/- 4.1 MONTHS OF FOLLOW-UP, TWO PATIENTS EXPERIENCED POCKET SEROMA, AND RESOLVED SPONTANEOUSLY AFTER SHORT-TERM ABDOMINAL BINDER COMPRESSION. OTHERWISE, NO SERIOUS COMPLICATION WAS NOTED. INTRATHECAL MORPHINE DELIVERY BY USING TOTALLY IMPLANTABLE PROGRAMMABLE IDDS IS AN EFFECTIVE METHOD TO RELIEVE REFRACTORY CANCER PAIN. REPORTED EVENT: PATIENT (B)(6) SUFFERED FROM POST-OPERATIVE POCKET SEROMA COMBINED WITH BACK WOUND SEROMA. THE SEROMA RESOLVED SPONTANEOUSLY AFTER SHORT-TERM USE OF ABDOMINAL BINDER COMPRESSION. THIS EVENT WAS PREVIOUSLY REPORTED WITH LIMITED PATIENT INFORMATION UNDER MANUFACTURER REPORT 3007566237-2012-01578.

    Description of Event or Problem · 1

    THE ARTICLE ALSO REPORTED: ¿THE BACK WOUND SEROMA MIGHT ALSO BE SECONDARY TO PERSISTENT CEREBROSPINAL FLUID (CSF) LEAKAGE.THIS IS LESS LIKELY IN OUR STUDY BECAUSE OUR PATIENTS DID NOT SHOW ANY OTHER SYMPTOMS RELATED TO PERSISTENT CSF LEAKAGE SUCH AS POSITIONAL HEADACHE. IN ADDITION, THEIR SEROMA RESOLVED SPONTANEOUSLY AFTER SHORT-TERM USE OF ABDOMINAL BINDER COMPRESSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention