BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2645498 · Received July 9, 2012

    Report

    Report Number
    3007566237-2012-01578
    Event Type
    Injury
    Date Received
    July 9, 2012
    Date of Event
    March 9, 2011
    Report Date
    June 18, 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

    THE ACTUAL EVENT DATES WERE NOT PROVIDED; THIS DATE IS BASED ON THE PUBLICATION DATE OF THE ARTICLE. IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4). PRODUCT TYPE: CATHETER. (B)(4). NOTE CORRECTION TO MANUFACTURER SITE ID, CORRECT VALUE IS 3004209178.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 SC ORES 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 EVENTS: ONE PATIENT SUFFERED FROM POST-OPERATIVE POCKET SEROMA. THE SEROMA RESOLVED SPONTANEOUSLY AFTER SHORT-TERM USE OF ABDOMINAL BINDER COMPRESSION. ONE PATIENT SUFFERED FROM POST-OPERATIVE POCKET SEROMA COMBINED WITH BACK WOUND SEROMA. THE SEROMA RESOLVED SPONTANEOUSLY AFTER SHORT-TERM USE OF ABDOMINAL BINDER COMPRESSION. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: THE PATIENT THAT EXPERIENCED THE POCKET SEROMA WAS PATIENT #3 AND THE PATIENT THAT EXPERIENCED BOTH POCKET AND BACK WOUND SEROMAS WAS PATIENT #6. THIS REPORT AND ANY FURTHER SUPPLEMENTALS WILL BE ONLY RELATED TO PATIENT #3. PLEASE SEE MANUFACTURER REPORT 3004209178-2012-09270 FOR INFORMATION RELATED TO PATIENT #6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention CATHETER MODEL: UNK, LOT #: UNK