MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Muscular Rigidity (1968)
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Event Date 04/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of concomitant medical products: product id neu_unknown_cath , serial# unknown , product type: catheter.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 baclofen (2000 mcg/ml at 325.4 mcg/day) via an implantable pump for intractable spasticity.It was reported that during normal pump replacement, it was seen the catheter was leaking.The rep stated the only symptom was more tone.The rep stated that they corrected the issue by doing a catheter revision on (b)(6) 2022.
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Manufacturer Narrative
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Continuation of d10: product id 8784 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type catheter product id 8781 lot# serial# (b)(6) implanted: (b)(6) 2018 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8784 serial/lot# (b)(6), ubd 2023-02-19, 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.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 neu_unknown_cath lot# serial# unknown implanted: explanted: 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 was received from the manufacturer representative (rep).They reported the cause of the leak was not determined.There were no external, environmental, or patient factors that may have cause or contributed to the leak.The replacement device resolved the event.
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Manufacturer Narrative
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Section d information references the main component of the system.Other relevant device(s) are: product id: 8781, serial/lot# (b)(6), ubd 2019-06-08, udi# (b)(4).H3 ¿ the locked in place catheter collet was returned for analysis.There was a small proximal catheter segment in one end.The small proximal catheter segment received was fully inserted onto the pin connector.There was no distal catheter segment in the other end.Analysis found ¿catheter pin connector ¿ collet prematurely locked in place¿.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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