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Index of reports
> Cases with Device Related Infection ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) where reactions include device related infection. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of Next >>
Possible Lioresal side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: female
Reactions: Sepsis, Device Related Infection, Cerebrovascular Accident
Adverse event resulted in: death
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Dilaudid; Droperidol; Bupivacaine HCL
Possible Lioresal side effects in 27 year old male
Reported by a physician from United States on 2012-07-23
Patient: 27 year old male
Reactions: Tinnitus, Drug Hypersensitivity, Implant Site Infection, Device Related Infection, Renal Failure, Staphylococcal Infection, NO Therapeutic Response, Meningitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Indication: Brain Injury
Lioresal
Indication: Cerebral Palsy
Lioresal
Indication: Head Injury
Possible Lioresal side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-22
Patient: male
Reactions: Device Related Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 259.1 mcg/day
Indication: Brain Injury
Lioresal
Dosage: 259.1 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-06-20
Patient: male
Reactions: Swelling, Pain, Device Related Infection, Erythema, Infection
Drug(s) suspected as cause:
Lioresal
Indication: Multiple Sclerosis
Lioresal
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: male
Reactions: Staphylococcal Infection, Device Related Infection, Intracranial Hypotension
Drug(s) suspected as cause:
Lioresal
Dosage: mcg, daily, intrath
Indication: Cerebral Palsy
Lioresal
Dosage: mcg, daily, intrath
Indication: Muscle Spasticity
Possible Lioresal side effects in 54 year old male
Reported by a physician from United States on 2012-05-31
Patient: 54 year old male
Reactions: Device Leakage, Wound Dehiscence, Tachycardia, Drug Withdrawal Syndrome, Wound Infection, Device Related Infection, Tremor
Drug(s) suspected as cause:
Lioresal
Indication: Multiple Sclerosis
Lioresal
Indication: Muscle Spasticity
Possible Lioresal side effects in female
Reported by a physician from United States on 2012-05-30
Patient: female
Reactions: DRY Skin, Device Related Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Indication: Muscle Spasticity
Lioresal
Indication: Spinal Cord Injury
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-05-17
Patient: male
Reactions: Implant Site Haematoma, Skin Erosion, Device Related Infection, Staphylococcus Test Positive, Enterobacter Test Positive
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 61 year old male
Reported by a physician from United States on 2012-05-17
Patient: 61 year old male
Reactions: Device Leakage, Wound Dehiscence, Implant Site Discharge, Device Related Infection, Incision Site Erythema, Purulent Discharge
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 2012-05-15
Patient: male
Reactions: Suture Rupture, Device Related Infection, Implant Site Erythema, Fall, Implant Site Swelling
Drug(s) suspected as cause:
Lioresal
Dosage: 750 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 750 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in 46 year old male
Reported by a physician from United States on 2012-05-03
Patient: 46 year old male
Reactions: Cellulitis, Body Temperature Increased, Nausea, Headache, Device Related Infection, Soft Tissue Infection, Renal Failure, Post Lumbar Puncture Syndrome, Acute Sinusitis, Chronic Sinusitis, Musculoskeletal Stiffness, Meningitis, Intracranial Hypotension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Indication: Spinal Cord Injury
Lioresal
Indication: Spinal Cord Disorder
Lioresal
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-05-03
Patient: male
Reactions: Osteomyelitis, Device Related Infection, Bacterial Test Positive, Device Battery Issue
Drug(s) suspected as cause:
Lioresal
Dosage: 359.8 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 359.8 mcg/day
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 27 year old female
Reported by a physician from United States on 2012-04-26
Patient: 27 year old female
Reactions: Post Procedural Complication, Implant Site Effusion, Muscle Spasticity, Device Related Infection, Implant Site Abscess, Device Breakage
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 14 year old male
Reported by a physician from United States on 2012-04-17
Patient: 14 year old male
Reactions: Pain, Pseudomonas Infection, Meningitis, Device Related Infection, Erythema
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-17
Patient: male
Reactions: Underdose, Device Related Infection, Device Connection Issue, Muscle Spasticity, Device Dislocation
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: Implant Site Effusion, Device Connection Issue, Device Related Infection, Implant Site Erythema, Fall, Implant Site Swelling
Drug(s) suspected as cause:
Lioresal
Dosage: 750 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 750 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-04-06
Patient: male
Reactions: Suture Rupture, Incision Site Oedema, Device Related Infection, Fall, Incision Site Erythema
Drug(s) suspected as cause:
Lioresal
Dosage: 750 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 750 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-03-28
Patient: male
Reactions: Wound Dehiscence, Device Related Infection
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-03-13
Patient: male
Reactions: Bacterial Infection, Device Related Infection, CSF Culture Positive
Drug(s) suspected as cause:
Lioresal
Dosage: 359.8 mcg day
Indication: Muscle Spasticity
Lioresal
Dosage: 359.8 mcg day
Indication: Cerebral Palsy
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-02-28
Patient: male
Reactions: Osteomyelitis, Bacterial Infection, Device Related Infection, CSF Culture Positive, Shunt Infection
Drug(s) suspected as cause:
Lioresal
Indication: Cerebral Palsy
Lioresal
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-24
Patient: male
Reactions: Implant Site Infection, Device Related Infection, Device Dislocation
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 male
Reported by a physician from United States on 2012-02-23
Patient: male
Reactions: Implant Site Discharge, Implant Site Pain, Device Related Infection, Implant Site Erythema, Wound Infection Staphylococcal, Implant Site Swelling
Drug(s) suspected as cause:
Lioresal
Indication: Multiple Sclerosis
Lioresal
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-02-21
Patient: male
Reactions: Vomiting, Staphylococcal Infection, Pyrexia, Device Related Infection, Erythema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Ibuprofen (Advil)
Possible Lioresal side effects in 17 year old male
Reported by a physician from United States on 2012-02-13
Patient: 17 year old male
Reactions: Drug Withdrawal Syndrome, Device Related Infection, Muscle Spasticity, Convulsion, Urinary Tract Infection Enterococcal, Cardio-Respiratory Arrest, Respiratory Failure, Meningitis Bacterial, Hypertension, Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Lioresal
Dosage: 1730 mcg/day
Indication: Cerebral Palsy
Lioresal
Dosage: 1730 mcg/day
Indication: Muscle Spasticity
Possible Lioresal side effects in 46 year old male
Reported by a physician from United States on 2012-02-10
Patient: 46 year old male
Reactions: Cellulitis, Nausea, Body Temperature Increased, Post Procedural Complication, Headache, Device Related Infection, Soft Tissue Infection, Renal Failure, Acute Sinusitis, Chronic Sinusitis, Musculoskeletal Stiffness, Meningitis, Intracranial Hypotension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Indication: Spinal Cord Injury
Lioresal
Indication: Muscle Spasticity
Possible Lioresal side effects in male
Reported by a physician from United States on 2012-01-31
Patient: male
Reactions: Suture Rupture, Incision Site Complication, Device Related Infection, Device Dislocation, Fall
Drug(s) suspected as cause:
Lioresal
Dosage: 750 mcg/day
Indication: Muscle Spasticity
Lioresal
Dosage: 750 mcg/day
Indication: Cerebral Palsy
Possible Lioresal side effects in 8 year old male
Reported by a physician from United States on 2011-12-02
Patient: 8 year old male
Reactions: Pruritus, Implant Site Infection, Drug Withdrawal Syndrome, Device Related Infection, Device Occlusion, Hyperhidrosis, Implant Site Reaction, Limb Discomfort, NO Therapeutic Response, Musculoskeletal Stiffness, Skin Infection, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Possible Lioresal side effects in 61 year old male
Reported by a physician from United States on 2011-10-14
Patient: 61 year old male
Reactions: Device Related Infection, Device Malfunction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lioresal
Other drugs received by patient: Morphine
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