MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/26/2022 |
Event Type
Injury
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Event Description
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Information was received from a healthcare provider (hcp) via a company representative (rep) regarding a patient receiving baclofen (1000 mcg/ml, 137.6 mcg/day ) via intrathecal infusion pump indicated for intractable spasticity.It was reported that a catheter revision was completed on (b)(6) 2022.The patient started experiencing withdrawal symptoms on (b)(6) 2022 and the hcp tried to aspirate from the catheter access port (cap) chamber on (b)(6) 2022 and was unable to do so.During the revision procedure they opened up the pocket and aspirated from the cap and were able to get good flow.The new pump segment was used and attached to the pump.The drug concentration was changed from 1000 to 500 mcg/ml.Technical services assisted with programming needed prime and bridge boluses.Also, discussed modified bridge bolus.The hcp was going to increase the dose from 75 mcg/day.The rep did not have the actual dose yet, but knew it would be greater than 75 mcg/day.
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Manufacturer Narrative
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Product id: neu_unknown_cath, lot#: unknown, serial#: unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown/unknown.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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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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Manufacturer Narrative
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Continuation of d10: product id 8780 lot# unknown serial# (b)(6) implanted: (b)(6) 2019 product type catheter.Section d information references the main component of the system.Other relevant device(s) are: product id 8780 serial# (b)(6) implanted: (b)(6) 2019 ubd: 2021-01-23 udi#: (b)(4) 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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Additional information received from a manufacturer representative (rep) indicated that the cause of the inability to aspirate the catheter access port (cap) was unknown.The patient's withdrawal symptoms resolved after the catheter revision.The patient's weight was asked but unknown.
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Search Alerts/Recalls
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