Concomitant medical products : product id 8598a serial# (b)(4); implanted: (b)(6) 2011; explanted: (b)(6) 2023.Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 28-feb-2013, 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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It was reported that the patient had increased pain, headaches, withdrawal and swelling in their back by the catheter.It was reported the patient was admitted to the hospital. there were no environmental, external, patient factors that may have led or contributed to the issue.The diagnostics/troubleshooting performed was imaging was performed which showed the catheter was out of the intrathecal (it) space.The actions/interventions taken to resolve the issue was the patient was taken to surgery and the spinal segment of the catheter was replaced with a new spinal piece. the issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿. the patient¿s weight and medical history were asked but unknown.
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