BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIORESAL

    MDR report key: 3943462 · Received July 18, 2014

    Report

    Report Number
    3007566237-2014-02003
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON (B)(6) 2013, THE PATIENT HAD AN INTRATHECAL LIORESAL (BACLOFEN) TRIAL. THE TRIAL WENT WELL AND THE PATIENT HAD GOOD EFFECT. THE PATIENT WAS ADMITTED TO HAVE AN ¿ENT¿ PROCEDURE THE FOLLOWING DAY AND RETURNED HOME AT THE END OF THE WEEK. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (E.R.) WITH WORSENING LOW BACK PAIN, NECK PAIN AND DIZZINESS UPON STANDING. THERE WAS NO DRAINAGE FROM THE LUMBAR PUNCTURE SITE, REDNESS, PSEUDOMENINGOCELE OR HEADACHE. AN MRI WAS SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THAT THE TRIAL WAS DONE BY INJECTION. NO CATHETER WAS INVOLVED. THE CONCENTRATION OR DOSE OF LIORESAL GIVEN TO THE PATIENT DURING THE TRIAL WAS 50MCG. AN MRI RULED OUT ASEPTIC MENINGITIS. AS OF (B)(6) 2013, THE PATIENT REMAINED IMPATIENT AND WAS STILL BEING ¿WORKED UP.¿ IT WAS LATER REPORTED THAT, WITHIN 3-4 HOURS OF THE TEST DOSE ADMINISTRATION, THE PATIENT BEGAN COMPLAINING OF LOW BACK PAIN, RADIATING ROSTRAL. THE PATIENT ALSO EXPERIENCED LEG PAIN AND A DECONDITIONED STATE. THE SYMPTOMS PERSISTED FOR 3 WEEKS WITH VERY GRADUAL RESOLUTION. MRIS OF THE TOTAL SPINE AND BRAIN WERE DONE ON (B)(6) 2013 AND WERE BOTH UNREMARKABLE. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2013. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO AN INPATIENT REHABILITATION FACILITY DUE TO MOBILITY RESTRICTIONS ASSOCIATED WITH PROLONGED PAIN. MULTIPLE TEAM WORK-UPS WERE DONE, WHICH WERE INCONCLUSIVE AND REVEALED NO DEFINITIVE RATIONALE FOR THE PAIN. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS INDICATED TO BE ¿SERIOUS INJURY/ILLNESS-ONGOING.¿ THE ONE TIME DOSE OF LIORESAL GIVEN WAS 37.5MCG WITH A CONCENTRATION OF 500MCG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423024 LIORESAL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8563S N365632

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR Hospitalization