BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 4245188 · Received November 12, 2014

    Report

    Report Number
    3007566237-2014-03301
    Event Type
    Injury
    Date Received
    November 12, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THESE EVENTS WITH ANY PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, LOT # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    STEVENSON V. L. INTRATHECAL BACLOFEN IN MULTIPLE SCLEROSIS. EUROPEAN NEUROLOGY. 2014; 72 SUPPL 1:32-34. SUMMARY: MANY PATIENTS WITH SEVERE MULTIPLE SCLEROSIS (MS)-RELATED SPASTICITY HAVE AN INADEQUATE RESPONSE OR POOR TOLERABILITY TO ORAL ANTISPASTICITY MEDICATIONS. BEFORE TAKING THE DECISION TO ESCALATE THERAPY, IT IS IMPORTANT TO REVIEW THE TRIGGER FACTORS FOR SPASTICITY (BLADDER, BOWEL, SKIN) AND OPTIMIZE THE PHYSICAL MANAGEMENT PROGRAM. IF ESCALATION THERAPY IS STILL REQUIRED, OPTIONS TO CONSIDER INCLUDE INTRATHECAL BACLOFEN. THIS REVIEW EXAMINES THE USE OF INTRATHECAL BACLOFEN. REPORTED EVENTS: -THERE WERE TEN CASES OF CATHETER DYSFUNCTION REQUIRING REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728748 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention