BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3170247 · Received June 14, 2013

    Report

    Report Number
    6000030-2013-00153
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    August 7, 2012
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. . THE ACTUAL EVENT DATE WAS NOT PROVIDED; THIS DATE IS BASED ON THE ARTICLE WAS ACCEPTED FOR PUBLICATION. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    VAN DER PLAS, A. A., VAN RIJN, M. A., MARINUS, J., PUTTER, H., VAN HILTEN, J. J. EFFICACY OF INTRATHECAL BACLOFEN ON DIFFERENT PAIN QUALITIES IN COMPLEX REGIONAL PAIN SYNDROME. ANESTHESIA ANALGESIA. 2013. 116(1). 211-215. DOI: 10.1213/ANE.0B013E31826F0A2E. SUMMARY: IN THIS STUDY, WE EVALUATED THE DIFFERENTIAL EFFECTS OF CENTRAL G-AMINOBUTYRIC ACID (B) RECEPTOR STIMULATION ON THE DIFFERENT PAIN QUALITIES IN CRPS PATIENTS WITH DYSTONIA. THE 10 PAIN QUALITIES OF THE NEUROPATHIC PAIN SCALE, DYSTONIA SEVERITY, AND CHANGES IN USE OF ANTINOCICEPTIVE DRUGS WERE EVALUATED EVERY 3 MONTHS FOR A PERIOD OF 1 YEAR IN 42 CRPS PATIENTS WITH DYSTONIA RECEIVING TITRATED DOSES OF INTRATHECAL BACLOFEN (ITB) TREATMENT IN AN OPEN DESIGN. USING A LINEAR MIXED MODEL ANALYSIS AND CONTROLLING FOR GLOBAL DYSTONIA SEVERITY AND THE USE OF SUPPLEMENTAL ANALGESICS, WE FOUND A SIGNIFICANT IMPROVEMENT IN GLOBAL INTENSE PAIN, SHARP PAIN, DULL PAIN, AND DEEP PAIN DURING THE FIRST 6 MONTHS. AFTER THIS PERIOD, THE SCORES LEVELED OFF DESPITE FURTHER IMPROVEMENT OF DYSTONIA AND CONTINUED ITB DOSE ESCALATION. G-AMINOBUTYRIC ACID (B) RECEPTOR STIMULATION BY ITB EXERTS DIFFERENTIAL ANTINOCICEPTIVE EFFECTS ON SPECIFIC PAIN QUALITIES IN CRPS PATIENTS WITH DYSTONIA. PLEASE NOTE THIS PATIENT WAS PREVIOUSLY REPORTED WITH LIMITED INFORMATION ON MANUFACTURER REPORT 3007566237-2013-00730. SEE LITERATURE ARTICLE ATTACHED TO MANUFACTURER REPORT 3007566237-2013-00730. THROUGH FOLLOW-UP WITH THE CORRESPONDING AUTHOR IT WAS DISCOVERED THAT PATIENT 22 EXPERIENCED POSTDURAL PUNCTURE HEADACHE, SOMNOLENCE, PSYCHOSIS, DEPRESSION AND ANXIETY DISORDERS AND A PUMP POCKET INFECTION. THE PATIENT WAS GIVEN A BLOODPATCH, ITB LOWERED, AND MEDICATION FOR INTERVENTIONS. THE PATIENT WAS RECEIVING COMPOUNDED BACLOFEN 3,000 MCG/ML, 630 MCG/DAY. THE SERIAL NUMBER PROVIDED FOR THIS PATIENT IN THE FOLLOW-UP RESPONSE IS THE SAME AS THAT PROVIDED FOR PATIENT #(B)(6), REPORTED UNDER MANUFACTURER REPORT 6000030-2013-00146. IT IS IMPOSSIBLE TO TELL FOR WHICH PATIENT THE SERIAL NUMBER IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270814 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8627L-18 CC116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention