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

 
 



Index of reports > Cases with Device Dislocation (44)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lioresal (Baclofen Intrathecal) where reactions include device dislocation. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 44   Next >>

Possible Lioresal side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female

Reactions: Muscle Spasticity, Headache, Device Dislocation, Drug Tolerance, Musculoskeletal Stiffness, Unevaluable Event, Adhesion, Hypertonia, Peritoneal Necrosis, Abnormal Behaviour, Condition Aggravated, Underdose, Posture Abnormal, Drug Withdrawal Syndrome, Paraesthesia, Convulsion, Peritonitis, Dysarthria, Nervous System Disorder, Gastric Volvulus, Feeling Abnormal, Device Breakage, Infection, Infusion Site Cyst

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy

Lioresal
    Dosage: see b5
    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: Muscle Spasticity, Headache, Device Dislocation, Muscle Tightness, Device Occlusion, Drug Tolerance, Peritoneal Necrosis, Hypertonia, Postoperative Adhesion, Mass, Abnormal Behaviour, Drug Withdrawal Syndrome, Posture Abnormal, Gastric Disorder, Paraesthesia, Peritonitis, Convulsion, Dysarthria, Gastric Volvulus, Nervous System Disorder, Feeling Abnormal, Device Breakage, Infection

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity

Lioresal
    Dosage: see b5
    Indication: Cerebral Palsy



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-09

Patient: male

Reactions: Burning Sensation, Drug Effect Decreased, Incorrect Dose Administered, Device Dislocation, Device Breakage, Feeling Cold

Drug(s) suspected as cause:
Lioresal
    Dosage: 99.92 mcg/day; see b5
    Indication: Cerebral Palsy

Lioresal
    Dosage: 99.92 mcg/day; see b5
    Indication: Muscle Spasticity



Possible Lioresal side effects in 41 year old female

Reported by a physician from United States on 2012-06-14

Patient: 41 year old female

Reactions: Tachycardia, Drug Withdrawal Syndrome, Withdrawal Syndrome, Device Dislocation, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal

Other drugs received by patient: Bupivacaine HCL; Fentanyl; Clonidine



Possible Lioresal side effects in 45 year old female

Reported by a physician from United States on 2012-05-17

Patient: 45 year old female

Reactions: Pseudomeningocele, Wound, Device Dislocation, Device Breakage, Intracranial Hypotension

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 2012-05-17

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 male

Reported by a physician from United States on 2012-05-16

Patient: male

Reactions: Vomiting, Photophobia, Implant Site Infection, Headache, Muscle Spasticity, Constipation, Device Dislocation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal



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 female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-02

Patient: female

Reactions: Device Kink, Pain, Device Inversion, Pyrexia, Drug Withdrawal Syndrome, Device Dislocation, Hyperhidrosis, Convulsion, Irritability, Volvulus, Muscle Spasms, Heart Rate Abnormal, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 493.0 mcg/day
    Indication: Cerebral Palsy

Lioresal
    Dosage: 493.0 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 45 year old female

Reported by a physician from United States on 2012-04-26

Patient: 45 year old female

Reactions: Incision Site Pain, Cellulitis, Incision Site Infection, Impaired Healing, Wound Dehiscence, Device Dislocation

Drug(s) suspected as cause:
Lioresal
    Dosage: 90 mcg, daily, intrathe
    Indication: Pain

Lioresal
    Dosage: 90 mcg, daily, intrathe
    Indication: Spinal Laminectomy



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 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 female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: female

Reactions: Pruritus, Hypotension, Muscle Spasticity, Drug Withdrawal Syndrome, Device Occlusion, Somnolence, Device Dislocation, Implant Site Swelling, Therapeutic Response Decreased, Multiple Drug Overdose, Bradycardia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: female

Reactions: Skin Disorder, Device Dislocation

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-04-18

Patient: female

Reactions: NO Therapeutic Response, Musculoskeletal Stiffness, CSF Pressure Increased, Device Connection Issue, Device Dislocation

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 2012-04-17

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 female

Reported by a physician from United States on 2012-04-16

Patient: female

Reactions: Implant Site Pain, Device Dislocation, Implant Site Swelling

Drug(s) suspected as cause:
Lioresal



Possible Lioresal side effects in female

Reported by a physician from United States on 2012-04-13

Patient: female

Reactions: Economic Problem, Implant Site Reaction, Pain, Hypotonia, Underdose, Feeling Abnormal, Device Dislocation

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



Possible Lioresal side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-10

Patient: female

Reactions: Device Leakage, Weight Decreased, Drug Effect Decreased, Device Extrusion, Condition Aggravated, Muscle Spasticity, Mood Swings, Device Dislocation

Drug(s) suspected as cause:
Lioresal
    Indication: Muscle Spasticity

Lioresal
    Indication: Multiple Sclerosis



Possible Lioresal side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-04

Patient: male

Reactions: Incorrect Route of Drug Administration, Medical Device Complication, Abnormal Behaviour, Nervous System Disorder, Device Connection Issue, Device Dislocation, Scar

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 2012-04-04

Patient: male

Reactions: Device Dislocation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: see b5
    Indication: Head Injury

Lioresal
    Dosage: see b5
    Indication: Brain Injury

Lioresal
    Dosage: see b5
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a physician from United States on 2012-04-03

Patient: male

Reactions: Vomiting, Photophobia, Implant Site Infection, Muscle Spasticity, Headache, Constipation, Device Dislocation, Post Procedural Infection

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 2012-03-15

Patient: female

Reactions: Nasopharyngitis, Device Kink, Device Damage, Drug Withdrawal Syndrome, Muscle Spasticity, Device Dislocation, Fall, Device Leakage, Poor Quality Sleep, Device Connection Issue, Urinary Retention, Hypertonia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lioresal
    Dosage: 236 mcg/day
    Indication: Cerebrovascular Accident

Lioresal
    Dosage: 236 mcg/day
    Indication: Muscle Spasticity



Possible Lioresal side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-14

Patient: male

Reactions: Catheter Site Swelling, Device Dislocation, Catheter Site Infection

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 18 year old male

Reported by a physician from United States on 2012-03-13

Patient: 18 year old male

Reactions: Incorrect Route of Drug Administration, Pneumonia Aspiration, Hypotension, Abnormal Behaviour, Implant Site Effusion, Muscle Tightness, Device Dislocation, Accidental Overdose, Procedural Vomiting, Implant Site Induration

Adverse event resulted in: life threatening event, 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 health professional (non-physician/pharmacist) from United States on 2012-03-01

Patient: male

Reactions: Catheter Site Swelling, Device Dislocation, Catheter Site Infection

Drug(s) suspected as cause:
Lioresal
    Dosage: 96 mcg/day
    Indication: Muscle Spasticity

Lioresal
    Dosage: 96 mcg/day
    Indication: Cerebral Palsy



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