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Model Number 8780 |
Device Problems
Difficult to Advance (2920); Infusion or Flow Problem (2964)
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Patient Problem
Ambulation Difficulties (2544)
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Event Date 12/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a healthcare provider via a company representative regarding a patient receiving an unknown drug.It was reported that the physician attempted twice to insert the tuohy needle and advance the catheter to the desired level of t8.Both times, the catheter stopped at the same spot at t10.Also both times after placement and stylet removal, there was no flow from the catheter.It appeared, with the injection of dye, that the catheter was intrathecal, but the physician was not comfortable moving forward without free flow from the catheter and the inability to aspirate fluid.It was unknown if there were any environmental, external or patient factors that may have led or contributed to the issue.Diagnostics and troubleshooting performed was 2 attempts to advance the catheter.The actions and interventions taken to resolve the issue was the catheter was removed and never implanted.The patient¿s incision was closed and the patient was kept for observation for a few hours.The patient began to complain of being unable to walk and had severe radicular pain after the procedure was aborted.She had to be transported to the hospital.The patient status was noted as alive, with injury, the patient was unable to walk and had severe radicular pain.
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Manufacturer Narrative
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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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Event Description
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Additional information was received from the healthcare provider indicated that the cause of the aspiration issue was unknown.It was reported that a discharge procedure was performed to resolve the patient's symptoms.
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Search Alerts/Recalls
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