Index of reports
> Cases with Device Malfunction (43)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) where reactions include device malfunction. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 43 Next >>
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-08-03
Patient: male
Reactions: Medical Device Change, Implant Site Infection, Implant Site Erythema, Device Malfunction
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male
Reactions: Coma, Pyrexia, Muscle Rigidity, Somnolence, Speech Disorder, Device Malfunction, Incorrect Dose Administered by Device, Product Quality Issue, Blood Pressure Increased, Dysphagia, Rash, Dysarthria, Dysstasia, Hallucination, Visual, Feeding Disorder, Asthenia, Feeling Drunk
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see image
Indication: Cerebral Palsy
Lioresal
Dosage: see image
Indication: Muscle Spasticity
Other drugs received by patient: SEE Image
Possible Lioresal side effects in male
Reported by a physician from Canada on 2012-06-14
Patient: male
Reactions: Blood Pressure Increased, Contusion, Complication of Device Removal, Pyrexia, Muscle Spasticity, Autonomic Dysreflexia, Convulsion, Renal Failure, Overdose, Consciousness Fluctuating, Insomnia, Hypotonia, Device Malfunction, Self-Medication
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 2012-06-07
Patient: female
Reactions: Rhabdomyolysis, Dystonia, Coma, Device Damage, Drug Withdrawal Syndrome, Muscle Spasticity, Device Leakage, Overdose, Device Connection Issue, Device Malfunction
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Cerebral Palsy
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-05-31
Patient: male
Reactions: Pneumonia, Pump Reservoir Issue, Implant Site Pain, Abnormal Behaviour, Drug Withdrawal Syndrome, Device Occlusion, Implant Site Swelling, Malaise, Oedema Peripheral, Injury, Device Malfunction, Hypertonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 450.2 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 450.2 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-05-18
Patient: female
Reactions: Rhabdomyolysis, Dystonia, Coma, Device Damage, Muscle Spasticity, Device Leakage, Overdose, Device Connection Issue, Withdrawal Syndrome, Device Malfunction
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Cerebral Palsy
Possible Lioresal side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: female
Reactions: Device Kink, Pain, Condition Aggravated, Muscle Spasticity, Device Malfunction, Device Dislocation, Disease Progression
Drug(s) suspected as cause:
Lioresal
Dosage: see b5 mcg, daily, intr
Indication: Multiple Sclerosis
Lioresal
Dosage: see b5 mcg, daily, intr
Indication: Muscle Spasticity
Possible Lioresal side effects in 9 year old female
Reported by a physician from United States on 2012-05-16
Patient: 9 year old female
Reactions: Irritability, Clonus, Condition Aggravated, Drug Withdrawal Syndrome, Muscle Spasticity, Adhesion, Device Malfunction, Muscle Spasms
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 12 year old male
Reported by a physician from United States on 2012-05-15
Patient: 12 year old male
Reactions: Back Pain, Mydriasis, Pyrexia, Somnolence, Overdose, Hypopnoea, Hypotonia, Bradycardia, Device Malfunction, Altered State of Consciousness, Lethargy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 8 year old male
Reported by a physician from United States on 2012-04-30
Patient: 8 year old male
Reactions: Pruritus, Implant Site Infection, Condition Aggravated, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Hyperhidrosis, Therapeutic Response Decreased, Implant Site Reaction, Limb Discomfort, Implant Site Scar, Musculoskeletal Stiffness, Device Connection Issue, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: male
Reactions: Pain, Urinary Incontinence, Coma, Pyrexia, Somnolence, Muscle Rigidity, Overdose, Device Malfunction, Product Quality Issue, Blood Pressure Increased, Dysphagia, Drug Withdrawal Syndrome, Rash, Dysarthria, Dysstasia, Hallucination, Visual, Mental Disorder, Feeding Disorder, Feeling Drunk, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Cerebral Palsy
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-26
Patient: male
Reactions: Device Component Issue, Excoriation, Urinary Tract Infection, Mental Status Changes, Muscle Spasticity, Device Related Infection, Device Occlusion, Device Dislocation, Device Leakage, Drug Withdrawal Convulsions, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 400 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 400 mcg/day
Indication: Spinal Cord Injury
Possible Lioresal side effects in 31 year old female
Reported by a physician from United States on 2012-04-25
Patient: 31 year old female
Reactions: Agitation, Pruritus, Drug Ineffective, Muscle Spasticity, Device Dislocation, Malaise, Overdose, Injury, Device Connection Issue, Device Malfunction, Hypersomnia, Pain in Extremity, Drug Withdrawal Syndrome, Discomfort, Device Failure, Device Breakage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-24
Patient: female
Reactions: Lung Disorder, Muscle Contracture, General Physical Health Deterioration, Device Malfunction, Treatment Noncompliance
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Cerebral Palsy
Possible Lioresal side effects in 9 year old female
Reported by a physician from United States on 2012-04-20
Patient: 9 year old female
Reactions: Clonus, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Irritability, Adhesion, Device Malfunction, Hypertonia, 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 2012-04-19
Patient: male
Reactions: Pruritus, Skin Graft, Formication, Drug Withdrawal Syndrome, Device Malfunction, Muscle Tightness, Feeling Abnormal
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 2012-04-19
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 56 year old male
Reported by a consumer/non-health professional from United States on 2012-04-19
Patient: 56 year old male
Reactions: Pain in Extremity, Drug Withdrawal Syndrome, Muscle Spasticity, Device Occlusion, Device Malfunction, Lymphoedema, Device Battery Issue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Morphine
Possible Lioresal side effects in 18 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-13
Patient: 18 year old male
Reactions: Hiccups, Pyrexia, Withdrawal Syndrome, Device Malfunction, Hypertonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Periactin; Valium; Oral Baclofen
Possible Lioresal side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-10
Patient: male
Reactions: Fall, Therapeutic Product Ineffective, Device Malfunction
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 13 year old male
Reported by a physician from United States on 2012-04-09
Patient: 13 year old male
Reactions: Clonus, Pain, Granuloma, Muscle Tightness, Tremor, Insomnia, Medical Device Site Reaction, Device Malfunction, Scar, Hypertonia
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 2012-04-02
Patient: female
Reactions: Drug Withdrawal Syndrome, Device Malfunction
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Morphine; Baclofen; Bupivicaine
Possible Lioresal side effects in 9 year old female
Reported by a physician from United States on 2012-03-30
Patient: 9 year old female
Reactions: Clonus, Condition Aggravated, Muscle Spasticity, Irritability, Adhesion, Withdrawal Syndrome, Device Malfunction, Hypertonia, Muscle Spasms
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 2012-03-28
Patient: female
Reactions: Nausea, Diarrhoea, Pain, Rhinorrhoea, Drug Withdrawal Syndrome, Device Malfunction, Abdominal Pain Upper
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: SEE Image
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-03-16
Patient: male
Reactions: Dystonia, Pyrexia, Hyperhidrosis, Device Malfunction, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1600 mcg/day, intrath
Indication: Brain Injury
Lioresal
Dosage: 1600 mcg/day, intrath
Indication: Muscle Spasticity
Lioresal
Dosage: 1600 mcg/day, intrath
Indication: Head Injury
Possible Lioresal side effects in 11 year old male
Reported by a physician from United States on 2012-03-08
Patient: 11 year old male
Reactions: Back Pain, Muscle Twitching, Paraesthesia, Burning Sensation, Myoclonus, Visual Impairment, Dizziness, Blood Pressure Decreased, Device Malfunction, Decreased Appetite
Drug(s) suspected as cause:
Lioresal
Dosage: 407.4 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 407.4 mcg/day
Indication: Cerebral Palsy
Possible Lioresal side effects in 23 year old female
Reported by a physician from United States on 2012-03-08
Patient: 23 year old female
Reactions: Pain, Insomnia, Condition Aggravated, Asthenia, Device Malfunction, Hypertonia, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 94.5 mcg, daily intrathecal
Indication: Muscle Spasticity
Lioresal
Dosage: 94.5 mcg, daily intrathecal
Indication: Cerebral Palsy
Possible Lioresal side effects in 44 year old female
Reported by a physician from United States on 2012-02-21
Patient: 44 year old female
Reactions: Confusional State, Spastic Paralysis, Pneumonia, Urinary Tract Infection, Cognitive Disorder, Disorientation, Suicidal Ideation, Cachexia, Anxiety, Disease Recurrence, Suicide Attempt, Mental Disorder, Multiple Sclerosis, Device Malfunction
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: see b5
Indication: Multiple Sclerosis
Lioresal
Dosage: see b5
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-13
Patient: female
Reactions: Drug Dose Omission, Confusional State, Vomiting, Pruritus, Disorientation, Aggression, Irritability, Balance Disorder, Hallucination, Visual, Drug Withdrawal Convulsions, Feeling Jittery, Insomnia, Memory Impairment, Device Malfunction, Crying
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1558.9mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 1558.9mcg/day
Indication: Brain Injury
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-02-10
Patient: female
Reactions: Contusion, Pain, Pseudomeningocele, Fall, Device Dislocation, Weight Increased, Device Leakage, Device Malfunction, Muscle Spasms
Drug(s) suspected as cause:
Lioresal
Dosage: 87.57 mcg, daily, intra
Indication: Surgical Failure
Lioresal
Dosage: 87.57 mcg, daily, intra
Indication: Pain
Other drugs received by patient: Dilaudid
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