MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 27-jul-2024, 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.
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Event Description
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Information was received from a healthcare professional (hcp) regarding a patient receiving morphine 10 mg/ml at min rate mode for non-malignant pain, and failed back surgery syndrome via an implantable pump.It was reported that the patient had been on min rate mode and using oral medications since their new catheter was implanted.The physician stated they were refilling the pump with a lower concentration drug 1 mg/ml and have to account for the 10 mg/ml drug in the system, and they could not achieve the dosing with the higher concentration.It was discussed removing system contents, min rate mode 84.6 days or a bridge bolus at a therapeutic 0.48 mg/day.The physician considered removing system contents if unable to aspirate min rate mode.Additional information was received reporting the hcp could not aspirate from the catheter access port and they were going to leave the pump programmed to min rate mode 84.6 days.
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Manufacturer Narrative
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Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6)2022.Product type catheter 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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(b)(6)2022 lfc(hcp): additional information received from the healthcare provider (hcp) regarding the patient information.The cause for unable to aspirate was unknown.The action/intervention that was taken to resolve unable to aspirate from the cap was replacing the catheter.Replacing new catheter resolved the issue.
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Search Alerts/Recalls
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