Information was received from a manufacturer's representative (rep) via a healthcare professional (hcp) regarding a patient receiving morphine (5mg/ml at 0.0307 mg/day) via an implantable infusion pump.The indication for use was spinal pain.It was reported that the patient had an mri today and still was not recovered earlier this morning.The pump was at minimum rate after reviewing the dosing /concentration.It was reported that they were planning on doing a catheter revision on the date of this report and they knew about three weeks ago there might be an issue.The rep wanted to know considerations with a pump that was stalled and need to do a catheter replacement.No patient symptoms were reported.Additional information was received from a company representative (rep) on 2023-mar-07 and it was reported the patient¿s weight would not be known.Regarding if the motor stall recovered, it was noted once the minimum flow was changed to a therapeutic rate, the motor stall recovered and resumed normal operating status.It was reported the pump was replaced for a smaller 20 oz based on the patient¿s size.Regarding the reason for revising the catheter, it was reported that the catheter was implanted too low in the thoracic area.The provider wanted to replace with a new catheter.The cause of the catheter issue was not determined and the catheter was replaced.The customer discarded devices.
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Concomitant medical products: product id: 8709, lot# j11267r27, implanted: (b)(6) 2002, explanted: (b)(6) 2023.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), 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.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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