Index of reports
> Cases with Medical Device Complication (47)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) where reactions include medical device complication. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 47 Next >>
Possible Lioresal side effects in 57 year old male
Reported by a physician from Germany on 2012-08-03
Patient: 57 year old male, weighing 82.0 kg (180.4 pounds)
Reactions: Device Leakage, Medical Device Complication, Psychotic Disorder, Urinary Tract Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-08-01
Patient: male
Reactions: Medical Device Complication, Intracranial Hypotension, Implant Site Swelling
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 800 mcg/day
Indication: Spinal Cord Injury
Lioresal
Dosage: 800 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-07-17
Patient: female
Reactions: Necrosis, Headache, Muscle Spasticity, Device Occlusion, Device Dislocation, Muscle Tightness, Implant Site Cyst, Musculoskeletal Stiffness, Hypertonia, Medical Device Complication, Condition Aggravated, Abnormal Behaviour, Implant Site Mass, Peritonitis, Paraesthesia, Convulsion, Implant Site Reaction, Dysarthria, Therapeutic Response Decreased, Hypotonia, Gastric Volvulus, Withdrawal Syndrome, Feeling Abnormal, Spinal Column Stenosis, Infection, Inflammation
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Lioresal
Dosage: see b5
Indication: Cerebral Palsy
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-07-16
Patient: female
Reactions: Medical Device Complication, Catheter Site Oedema
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Multiple Sclerosis
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-07-06
Patient: female
Reactions: Medical Device Complication, Incorrect Dose Administered, Implant Site Haematoma, Muscle Spasticity, Abdominal Pain Upper, Balance Disorder, Incision Site Infection, Device Connection Issue, Muscle Spasms, Back Disorder, Device Breakage
Drug(s) suspected as cause:
Lioresal
Dosage: 360.2 mcg/day
Indication: Spinal Cord Disorder
Lioresal
Dosage: 360.2 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 360.2 mcg/day
Indication: Spinal Cord Injury
Possible Lioresal side effects in male
Reported by a physician from Spain on 2012-06-27
Patient: male
Reactions: Medical Device Complication, Multi-Organ Failure, Condition Aggravated, Muscle Spasticity, Apallic Syndrome
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from Canada on 2012-06-26
Patient: male
Reactions: Drug Ineffective, Body Temperature Increased, Muscle Spasticity, Overdose, Dialysis, Self-Medication, Hypersomnia, Medical Device Complication, Condition Aggravated, Autonomic Dysreflexia, Convulsion, Renal Failure, Abdominal Rigidity, Consciousness Fluctuating, Hypotonia, Insomnia, Hypertension, Device Breakage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in
Reported by a physician from United States on 2012-06-18
Patient:
Reactions: Medical Device Complication, Haemorrhage, Subdural Hygroma, Hydrocephalus
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 17 year old male
Reported by a physician from France on 2012-06-18
Patient: 17 year old male
Reactions: Medical Device Complication
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 28 year old male
Reported by a physician from United States on 2012-06-15
Patient: 28 year old male
Reactions: Medical Device Complication, Contusion, Ecchymosis, Seroma
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Fentanyl
Possible Lioresal side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-15
Patient: female
Reactions: Medical Device Complication, Muscle Spasticity, Cognitive Disorder, Delirium, Hallucination
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: female
Reactions: Medical Device Complication, Alcohol Abuse, Device Damage, Implant Site Effusion, Muscle Spasticity, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 999.7 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 999.7 mcg/day
Indication: Stiff Person Syndrome
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: male
Reactions: Medical Device Complication, Drug Effect Decreased, Pruritus, Muscle Spasticity, Hypertension
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Spinal Cord Disorder
Lioresal
Indication: Spinal Cord Injury
Possible Lioresal side effects in 45 year old female
Reported by a physician from United States on 2012-05-15
Patient: 45 year old female
Reactions: Medical Device Complication, Post Lumbar Puncture Syndrome, Implant Site Pain, Implant Site Effusion, Spinal X-RAY Abnormal, Intracranial Hypotension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 54.99 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 54.99 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14
Patient: male
Reactions: Medical Device Complication, Drug Ineffective, Implant Site Infection, Adhesion, Device Dislocation, Implant Site Swelling
Drug(s) suspected as cause:
Lioresal
Dosage: 96 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 96 mcg/day
Indication: Cerebral Palsy
Possible Lioresal side effects in 49 year old male
Reported by a physician from Spain on 2012-05-14
Patient: 49 year old male
Reactions: Medical Device Complication, Blood Creatine Phosphokinase Increased, Fibrosis, Muscle Spasticity
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-05-08
Patient: male
Reactions: Medical Device Complication, Malaise, Oesophageal Disorder
Drug(s) suspected as cause:
Lioresal
Dosage: 00mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 00mcg/day
Indication: Brain Injury
Possible Lioresal side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-23
Patient: female
Reactions: Medical Device Complication, Multiple Sclerosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Dosage: 2000mcg/ml
Indication: Multiple Sclerosis
Lioresal
Dosage: 2000mcg/ml
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-20
Patient: female
Reactions: Medical Device Complication, Implant Site Effusion, Therapeutic Product Ineffective, Implant Site Oedema
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Multiple Sclerosis
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-04-19
Patient: female
Reactions: Thrombosis, Tongue Discolouration, Glossodynia, Pain, Coma, Headache, Device Dislocation, Device Malfunction, Medical Device Complication, Product Quality Issue, Pain in Extremity, Neuroma, Medical Device Pain, Ileus Paralytic, Burning Sensation, Device Leakage, Syncope, Arthritis Infective, Vision Blurred, Infection, Infected Skin Ulcer
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Bupivicaine; Morphine Sulfate
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-18
Patient: male
Reactions: Contusion, Wrist Fracture, Abasia, Pain, Fear, Hand Fracture, Fall, Suicidal Ideation, Foot Fracture, Concussion, Overdose, Procedural Complication, Dysgraphia, RIB Fracture, Muscle Spasms, Medical Device Complication, Nightmare, Nausea, Anxiety, Post-Traumatic Stress Disorder, Communication Disorder, Device Infusion Issue, Insomnia, Facial Bones Fracture, Homicidal Ideation, Withdrawal Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 61 year old male
Reported by a physician from United States on 2012-04-17
Patient: 61 year old male
Reactions: Medical Device Complication, Suture Related Complication, Device Related Infection, Implant Site Erythema, Implant Site Pustules
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Morphine
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-17
Patient: male
Reactions: Medical Device Complication, Arachnoiditis, Musculoskeletal Stiffness, Muscle Spasticity, Device Dislocation, Injury Associated With Device, Lethargy
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from Ireland on 2012-04-17
Patient: male
Reactions: Medical Device Complication, Staphylococcal Infection, Skin Necrosis
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-16
Patient: male
Reactions: Medical Device Complication, Pain in Extremity, Central Nervous System Mass, Dermal Cyst, Abscess, Spinal Cord Oedema, Excessive Granulation Tissue, Inflammation
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Valium; Elavil; Norco; Multi-Vitamin; Zestril; Depakote; Lasix; Levothroid
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-16
Patient: male
Reactions: Medical Device Complication, Implant Site Inflammation, Back Pain, Post Procedural Complication, Hypoaesthesia, Erythema, Granuloma, Paraesthesia, Groin Pain, Activities of Daily Living Impaired, Neck Pain, Feeling Abnormal
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Bupivacaine Intrathecal; Morphine
Possible Lioresal side effects in male
Reported by a individual with unspecified qualification from United States on 2012-04-13
Patient: male
Reactions: Medical Device Complication, Withdrawal Syndrome, Cardiac Arrest, Post Procedural Infection
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-12
Patient: male
Reactions: Muscle Atrophy, Device Occlusion, Device Computer Issue, Overdose, Hypoaesthesia Oral, Facial Paresis, Oedema Peripheral, Device Connection Issue, Lymphoedema, Blood Sodium Decreased, Muscle Spasms, Medical Device Complication, Polydipsia, Pain in Extremity, Diplegia, Hypotension, Condition Aggravated, Muscular Weakness, Cerebrovascular Accident, Arthralgia, NO Therapeutic Response, Hypotonia, Depressed Level of Consciousness, Withdrawal Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-04-12
Patient: female
Reactions: Medical Device Complication, Dystonia, Incorrect Dose Administered, Underdose, Fall, Convulsion, Disease Progression, Device Leakage, Overdose, Malaise, Withdrawal Syndrome, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-11
Patient: male
Reactions: Medical Device Complication, Overdose, Withdrawal Syndrome, Device Dislocation, Implant Site Swelling, Intracranial Hypotension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Brain Injury
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
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