MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Unspecified Infection (1930); Meningitis (2389)
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Event Date 03/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 8781.Serial#: (b)(4).Implanted: (b)(6) 2023 explanted: other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 09-feb-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.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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Information was received from a healthcare provider (hcp) regarding an implanted pump system for intractable spasticity and multiple sclerosis.The pump was used to deliver unknown baclofen.Dose and concentration information was unknown.It was reported that the patient was hospitalized on (b)(6) 2023 with a headache and meningitis was being ruled out.The reporter inquired about dosing details.The reporter was redirected to the patient's healthcare provider.
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Manufacturer Narrative
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Continuation of d10: product id 8781 lot# serial# (b)(6), implanted: (b)(6) 2023, explanted: (b)(6)2023, 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 a healthcare provider (hcp) via a company representative who reported that the patient had an infection post implant.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The full system was explanted in march, and a new system was implanted on (b)(6) 2023.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provider regarding the event.The pump was delivering lioresal (500 mcg/ml at 100 mcg/day).
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