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

 
 



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 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 2012-05-17

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 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 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 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 2012-04-26

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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