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

 
 



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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