BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5163293 · Received October 20, 2015

    Report

    Report Number
    6000030-2015-00156
    Event Type
    Injury
    Date Received
    October 20, 2015
    Date of Event
    October 21, 2012
    Report Date
    May 22, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WAS NOT POSSIBLE TO MATCH THIS EVENT TO A PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS MDR AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. (B)(4)

    Description of Event or Problem · 1

    GURSES, E., BERK, D. EFFICACY OF INTRATHECAL MORPHINE PUMP IN A CASE OF PERIPHERAL NEUROPATHIC PAIN DEVELOPED AFTER BORTEZOMIB. ANATOLIAN JOURNAL OF CLINICAL INVESTIGATION. 2012;6(4):271-273. SUMMARY: BORTEZOMIB IS A NEWLY-DEVELOPED PROTEOSOME INHIBITOR EFFECTIVE IN TREATING MANY TYPES OF CANCER. IT INHIBITS NUCLEAR FACTOR KAPPA B (NF-B) KNOWN TO CONSTITUTE THE MYELOMA CELL SIGNAL IN THE BONE MARROW AND IS THEREFORE COMMONLY USED ESPECIALLY IN CASES WITH NEWLY-DIAGNOSED OR RESISTANT MULTIPLE MYELOMA. THE MOST IMPORTANT SIDE EFFECT IS THAT IT CAUSES PERIPHERAL NEUROPATHIC PAIN AT A SEVERITY THAT MAY REQUIRE STOPPING TREATMENT. THE DRUG HAS BEEN SHOWN TO LEAD IN PARTICULAR TO AN AXONAL DEGENERATION IN THE PERIPHERAL NERVES AND DORSAL ROOT GANGLIA AND TO AFFECT THE PERIPHERAL AFFERENT AP, A, AND C FIBERS OFTEN IN EXPERIMENTAL STUDIES. WE USED INTRATHECAL MORPHINE PUMP IMPLANTATION IN THE CASE WHERE WE WERE UNABLE TO OBTAIN A RESPONSE TO HIGH DOSE SYSTEMIC TREATMENT. WE OBSERVED THAT THE PARESTHESIA, THERMAL HYPERALGESIA AND PAIN DISAPPEARED AFTER INTRATHECAL MORPHINE INJECTION AND THE PAIN THAT COULD NOT BE CONTROLLED WITH A 90 MG/DAY DOSE OF SYSTEMIC MORPHINE COMPLETELY RESOLVED WITH A 0.1 MG/DAY DOSE. WE BELIEVE THAT INTRATHECAL MORPHINE PUMP IMPLANTATION CAN ENABLE EFFECTIVE AND SAFE PAIN TREATMENT IN SMALL DOSES WITH THE LEAST SIDE EFFECTS IF THERE IS NO RESPONSE TO OTHER TREATMENT METHODS. REPORTED EVENT: THE (B)(6) MALE PATIENT EXPERIENCED URINARY RETENTION THAT DISAPPEARED 3-4 DAYS AFTER THE START OF ADMINISTRATION. SEE ATTACHED LITERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691924 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Other