Concomitant medical products: product id: neu_unknown_cath, lot#: unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.Event date: please note that this date is based off of the year of publication of the article, as the event dates were not provided in the published literature.Dekopov av, pashin dl, tomski aa, isaguljan ed, salova em, kamchatnov pr.[long-term results of chronic intrathecal baclofen tre atment in patients with spasticity and secondary dystonia].Zh nevrol psikhiatr im s s korsakova.2019;119(1):38-43.If information is provided in the future, a supplemental report will be issued.
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Summary: to estimate the efficacy of intrathecal treatment with baclofen (itb) in spasticity and dystonia.Reported events: the patients' medical history included spinal spasticity and cerebral spasticity (cerebral palsy).In 1 patient, symptoms of acute baclofen overdose were noted after air travel.The probable cause was the difference in atmospheric pressure during the flight.The complication was clinically manifested by the development of diffuse muscle weakness, drowsiness, followed by depression of consciousness to coma.The patient was hospitalized in the intensive care unit.Intrathecal infusion was stopped.30 ml of csf were evacuated through the catheter port.When evacuating the drug from the pump reservoir, a discrepancy with the estimated volume of 1 ml was revealed.A day later, the level of consciousness began to recover.Symptoms of a baclofen overdose completely regressed after 1 week.It was stated one complication was noted associated with an overdose of baclofen after air travel.Seromas formed in 2 patients.In one case, one patient 1 month after surgery, seroma occurred in the subcutaneous pocket of the pump.The contents of the pocket, the volume of which was 15¿20 ml, were periodically evaluated.Samples were sterile.Subsequently, the accumulation volume increased to 50 ml.The patient underwent a check-up and the pump casing was moved under the aponeurosis of the muscles of the anterior abdominal wall.However, 1 month after the operation, a relapse of the cluster with the formation of fistulas was noted in the area of the skin suture.The pump was removed.The samples remained sterile.In another case, the patient accumulated fluid in the projection of the pump casing on the 3rd day after the operation.A rise in body temperature to 38° was also noted.The patient underwent intensive antibacterial therapy, regular puncture of the pump pocket for 2 weeks.Samples and csf remained sterile; a slight increase in cytosis was noted (up to 200/3).After the patient developed an incurable fever with a rise in body temperature to 39°c, the pump was removed.The next day after removal of the pump, the temperature reaction and seroma regressed.In both cases, no growth of flora was detected in samples.However, seromas regressed only after removal of the system.It was stated inadequate intrathecalinfusion, which required surgical intervention, was noted.In 2 cases, a pump failure was detected.It was stated a patient had a rotation of the pump casing in the subcutaneous pocket due to the separation of the fixing ligatures.There were complications associated with the catheter.Clinically, this was manifested by a sharp decrease in the antispastic effect and the appearance of csf accumulation on the spine in the projection of the suture.In all cases, an x-ray examination verified catheter prolapse from the spinal canal.A possible cause of catheter migration in one case was intensive rehabilitation exercises, accompanied by torso inclinations.In another case, the patient had a rotation of the pump casing in the subcutaneous pocket due to the separation of the fixing ligatures.During the examination, twisting of the pump segment of the catheter into a node with separation from the spinal segment was revealed.After replacing the intrathecal catheter, the performance of the intrathecal infusion systems was fully restored.In 1 case, migration of the spinal catheter from the subarachnoid space was revealed.The reason for this could be pronounced hyperkinesis and dystonia in the muscles of the back.In 1 case, the patient fell off a horse onto the pump area (during a hippotherapy session), there was an accumulation of fluid in the subcutaneous pocket of the pump and a sharp decrease in the clinical effect of therapy.An x-ray examination verified the separation of the pump segment of the catheter from the pump.After the examination, the system was restored to functionality.
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