BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4669268 · Received April 8, 2015

    Report

    Report Number
    3007566237-2015-00928
    Event Type
    Injury
    Date Received
    April 8, 2015
    Report Date
    March 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. PRODUCT ID: NEU_ASCENDA_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    TAIRA, T., TAKEDA, N. INTRATHECAL BACLOFEN THERAPY FOR HEREDITARY SPASTIC PARAPLEGIA. CLINICAL NEUROLOGY. 2014; 54(12):1018-1020. DOI: 10.5692/CLINICALNEUROL.54.1018. SUMMARY: BACLOFEN PRODUCES AN ANTISPASMOGENIC EFFECT BY ACTING ON GABA-B RECEPTORS IN THE DORSAL HORN OF THE SPINAL CORD. HOWEVER, SINCE IT IS DIFFICULT TO PASS THROUGH THE BLOOD-BRAIN BARRIER, MINISCULE DOSES MUST BE CONTINUOUSLY ADMINISTERED TO THE CEREBROSPINAL FLUID CAVITY OF THE SPINAL CORD. INTRATHECAL BACLOFEN THERAPY (ITB) HAS BEEN ADMINISTERED IN OVER 1,100 CASES IN JAPAN, INCLUDING IN APPROXIMATELY 50 CASES OF HEREDITARY SPASTIC PARAPLEGIA (HSP). THE CHARACTERISTICS OF ADMINISTERING ITB IN CASES OF HSP INCLUDE 1) EFFECTS CAN BE SEEN WHEN ADMINISTERING A SMALLER DOSE THAN IS TYPICAL 2) LARGE VARIATIONS IN EFFECTIVENESS CAN BE SEEN WITH VERY SMALL VARIATIONS IN THE ADMINISTERED DOSAGE 3) WHEN ADMINISTERED FOR A LONG PERIOD THE DOSAGE CAN BE REDUCED. REGARDING IMPROVEMENT IN GAIT, A DEFINITIVE CONCLUSION HAS NOT BEEN REACHED REGARDING STIMULATION EFFECTIVENESS DURING TRIAL ADMINISTRATION. IT IS VERY EFFECTIVE IN MITIGATING PAIN BROUGHT ON BY MUSCLE SPASMS. COMPLICATIONS WERE DRASTICALLY REDUCED BY THE INTRODUCTION OF A NEW CATHETER. REPORTED EVENT: -THERE WERE 28 OCCURRENCES OF DISLODGEMENT OR MIGRATION IN INDURA CATHETERS. -THERE WERE 10 OCCURRENCES OF BREAKAGE IN INDURA CATHETERS. -THERE WERE 3 OCCURRENCES OF OBSTRUCTION OR KINKING IN INDURA CATHETERS. -THERE WERE 3 OCCURRENCES OF DISLODGEMENT OR MIGRATION IN ASCENDA CATHETERS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ALL THREE OF THE INDURA CATHETERS WITH AN OBSTRUCTION OR KINKING HAD REPORTEDLY KINKED. WHEN ADDRESSING WHAT OTHER OBSTRUCTIONS HAD OCCURRED, IT WAS STATED THAT THERE WAS "NOTHING SPECIAL". FOR ALL REPORTED EVENTS, IT WAS INDICATED THAT THERE WAS "NOTHING SPECIAL" WITH REGARDS TO WHETHER PATIENTS EXPERIENCED ANY SYMPTOMS. IT WAS REPORTED THAT ALL OF THE EVENTS WERE RESOLVED WITH REPLACEMENT AND THE PATIENTS RECOVERED FROM THEIR RESPECTIVE EVENTS WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232918 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention