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Lioresal (Baclofen Intrathecal) - Medical Device Complication - Suspected Cause - Side Effect Reports

 
 



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 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

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 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, 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 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 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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