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Model Number 8637-40 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
Event Type
malfunction
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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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Information was received from a manufacturer representative (rep) regarding a patient who was receiving unknown morphine drug (800 mg/ml at 139 mg/day) via an implantable pump for spinal pain indications.It was reported that the rep realized that they were missing information regarding the case as it related to splicing the catheter during a normal battery depletion pump replacement.The rep stated that the calculations they had done previously had been done with the wrong catheter volume so they wanted to confirm the new prime volume; however, the pump tubing volume was not included, therefore the pump's entire system was not primed.The rep noted that the patient had oral medication and is intrathecal naive for 2 years.No symptoms/patient complications were reported.
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Event Description
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Additional information received from the healthcare provider (hcp) via company representative (rep) clarified that the report of "splicing the catheter" was due to the patient having a legacy catheter so the hcp added a new pump attachment.The rep stated that they spoke to technical services who advised delay in the patient receiving medication.No withdrawal was reported.The issue was reported to be resolved.The patient's weight was asked but unknown.
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Manufacturer Narrative
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Continuation of d10: product id neu_unknown_prog lot# serial# unknown implanted: explanted: product type programmer, physician 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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Search Alerts/Recalls
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