Model Number 8637-20 |
Device Problem
Data Problem (3196)
|
Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 02/15/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal morphine (unknown concentration and dose) via an implanted pump for spinal pain indications.It was reported that the hcp saw error 112 when reading the pump indicating that there was invalid infusion information.The hcp checked the logs and there was nothing in the logs that indicated any sort of error.It was reported that the last log was from (b)(6) 2024 when the pump was refilled and updated.It was reported that the patient started having withdrawal type symptoms on (b)(6) 2024 and the patient has not reported any alarms and there were no active alarms showing when reading the pump.The patient stated that they have had loss of therapy over the past week and was wondering how to treat their symptoms.The caller stated that they updated to flex mode and waited for the patient to receive a bolus but did not see anything in the logs regarding the completion of the bolus or a change in volume.
|
|
Event Description
|
Additional information was from a healthcare provider (hcp) via a company representative stated that the patient weight was asked but unknown at this time.The rep will follow up next week for action/intervention/resolution.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Manufacturer Narrative
|
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
|
|
Event Description
|
Additional information was received from a healthcare provider (hcp) via a company representative (rep) reporting that the patient's weight at the time of the event was 145 pounds.It was reported that the pump settings were updated and the patient was back to baseline.
|
|
Search Alerts/Recalls
|