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 Problem
Convulsion/Seizure (4406)
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Event Date 04/11/2023 |
Event Type
Injury
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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.
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Event Description
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Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (500 mcg/ml at 75 mcg/ml) via an implanted pump.The indication for pump use was intractable spasticity.It was reported that last week, the patient had a new pump and catheter implanted for alexander¿s disease.The patient had a spinal fusion the same day as the pump implant.Since the implant, the patient had been more somnolent like they were getting too much medication.The patient¿s spasticity all went away, and they became too loose.The patient had a trial dose of 50 and the pump dose was started at 75 mcg/day.They had decreased the dose to the lowest therapeutic dose of 24 mcg/day with the patient¿s symptoms unchanged.All of the programming was checked, and no errors were seen.The hcp was going to refill the pump with saline and do the removing system contents procedure.Additional information was received on 20-apr-2023 from the hcp and the company representative who inquired about how many milliliters should be aspirated through the cap (catheter access port) so the physician could obtain csf (cerebrospinal fluid) for testing for bacteria.The patient¿s pump was currently in minimum rate mode.Per the reporter, the patient experienced a seizure last night.The patient had a history of seizures but had not had one in a while.The patient was not having any fevers.
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Event Description
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Additional information received reported that the patient had a non-complicated seizure and the doctor was unsure of what caused the seizure.The actions and interventions taken to resolve the issue was the patient would stay on min rate.No explant was planned and the pump would remain implanted at minimum rate.
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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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