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 Problems
Muscular Rigidity (1968); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id 8709sc lot# serial# (b)(4), implanted: on (b)(6) 2009, product type catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: 8709sc, serial #: (b)(4), ubd: 24-sep-2011, 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 healthcare professional (hcp) and manufacturer's representative (rep) regarding a patient receiving ba clofen (2000.0 mcg/ml at 351.4 mcg/day) via an implantable infusion pump.The indication for use was intractable spasticity.It was reported that the patient was in the hospital due to what they believe is baclofen withdrawal.It was reported that a rep came to the hospital.The pump was interrogated and confirmed all is well with the pump.The rep mentioned a dye study to check the catheter.It was reported that patient was improving but got worse and now they want to connect with the rep to perform a dye study.The patient was very spastic in the legs and crying out in pain.Additional information was received from a healthcare provider (hcp) via a company representative (rep) on (b)(6) 2023 indicated the patient had withdrawal symptoms and increase in pain post-pump replacement.It was reported that the rate increased twice.Normal use rate increased as the physician thought the increase in spasticity was only due to post-operative pain.A dye study performed on (b)(6) 2023 and no issues were confirmed.Another dye study was performed again on (b)(6) 2023 and dye pooling into the pocket instead of going through the catheter was observed.A pump connector revision was planned on (b)(6) 2023 to revise the connector piece in for pocket.The patient experienced withdrawals.The issue was not resolved at the time of report.The status of the patient at the time of report was "alive - with injury".The patient's weight and medical history were asked but will not be made available.
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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 received from a company representative (rep) reported the leak had been seen at the connector piece between the pump and catheter.The issue was reported to be resolved and the explanted portion of the catheter was reported to be lost.
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Search Alerts/Recalls
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