Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: ubd: 23-jun-2023, 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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Information was received from a consumer and a healthcare provider via a company representative regarding a patient receiving morphine via an implantable pump.It was reported the catheter was explanted and replaced.The patient did not have any signs or symptoms related to the issue.It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue.The actions and interventions taken to resolve the issue was they replaced with new catheter and placed at new level.Per the reporter, nothing was wrong with the catheter.The catheter wasn¿t placed at correct level so catheter was replaced with a new catheter and remainder was tied off.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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