Information was received from a healthcare provider via a company representative regarding a patient receiving baclofen 2250mcg/ml at 1000mcg/ml via an implantable pump.It was reported that the patient has significant spasticity.There were no environmental, external or patient factors that may have led or contributed to the issue.The diagnostics and troubleshooting performed was a rotor dye study was performed, the physician was unable to aspirate csf (cerebral spinal fluid) from cap (catheter access port).Injected dye but difficult to tell if dye showed in intrathecal space.No actions or interventions were taken to resolve the event at present.Surgical intervention did not occur and it was unknown if surgical intervention was planned.It was unknown if the issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.
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Concomitant medical products: product id 8780.Serial# (b)(4).Implanted: (b)(6) 2007.Product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4).Ubd: (b)(6) 2018, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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