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
Muscular Rigidity (1968)
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Event Date 05/17/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 26-jan-2023, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 05-feb-2023, udi#: (b)(4).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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (500 mccg/ml at 100 mcg/day) via an implantable pump for intractable spasticity.It was reported that the patient had been experiencing more and more spasticity since the initial implant.There were no factors that may have led or contributed to the issue.Logs were read and cap (catheter access port) aspiration was attempted on (b)(6) 2022 by managing healthcare provider staff.Cap aspiration was unsuccessful.The hcp was asked to revise the catheter on (b)(6) 2022.Upon examination, the hcp noted no spontaneous flow from the catheter nor was the hcp able to aspirate the catheter through the cap intra-operation.As the hcp worked from the pump back to the spinal incision making several cuts of the catheter to see if there was any flow.Not until the hcp pulled the catheter back quite a bit was the hcp able to see some dripping of csf (cerebrospinal fluid).The hcp decided at that point to replace the entire catheter as well as replace the pump even though there was no allegation of anything malfunctioning with the pump.The issue was resolved at the time of report.The patient's medical history was asked and will not be made available.The patient's status at the time of report was alive - no injury.
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Event Description
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Additional information stated the patient was receiving gablofen (2 000 mcg/ml and 399.9 mcg/day).
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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 8780 serial# (b)(6) implanted: (b)(6) 2021 explanted: (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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Manufacturer Narrative
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H3: analysis of catheter (s/n (b)(6)) identified an area of compression on the catheter body.Analysis of catheter (s/n (b)(6)) identified no anomalies.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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