MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Disconnection (1171)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Muscular Rigidity (1968); Seroma (2069); Cramp(s) /Muscle Spasm(s) (4521)
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Event Date 03/08/2023 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id 8709 lot# (b)(4) serial# implanted: (b)(6) 2001 product type catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), 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 via a company representative regarding a patient receiving baclofen 2000mcg/ml at 500mcg/day via an implantable pump.The indication for use was intractable spasticity.It was reported that the patient had new implant (b)(6) 2023 and shortly after the physician found a seroma and aspirated the fluid surrounded in the pocket.The patient came to the ed (emergency room) yesterday with increased spasticity.The physician aspirated 85cc¿s of clear fluid from the site.The physician believed the pump connector piece became disconnected and both drug and unknown fluid was aspirated.The physician did not believe this was an infection or pocket fill.Additional information received on 21-mar-2023 reported the patient had the catheter revision.The patient was having withdrawal and spasms.The catheter was disconnected from the pump.The physician replaced the pump connector and gave the patient a therapeutic bolus.
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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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Event Description
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Additional information was received from a company representative (rep) reporting that the catheter was disconnected from the pump and reattached.The provided information has been confirmed with the physician.
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Search Alerts/Recalls
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