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
Cerebrospinal Fluid Leakage (1772); Headache (1880); Fluid Discharge (2686); Swelling/ Edema (4577)
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Event Date 03/27/2023 |
Event Type
Injury
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Event Description
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On 2023-apr-05, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving an unknown drug via an implantable pump.It was reported the patient had a pump and catheter replacement on 2023-mar-27.Their daily dose was decreased to 100 mcg/day (2,000 mcg/ml) of baclofen.The patient was admitted and discharged the next day.On (b)(6) 2023, the patient followed up with their hcp who managed their pump.The patient had swelling around the pump site, drainage from the pump site and a positional headache.A blood patch was done and the patient was sent home.The patient then appeared back in the emergency room (er) later in the pm and was transferred to another hospital for exploration of the pump and catheter site.The patient still had a positional headache.It was stated they would be taken back to surgery on (b)(6) 2023 to explore the pump site and catheter site.The issue was not resolved at the time of this report.
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Manufacturer Narrative
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Concomitant medical products: product id 8780 serial# (b)(4).Implanted: (b)(6) 2023 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 11-aug-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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Additional information was received from a company representative (rep) reporting that the patient had a csf leak from the old catheter site where it was explanted.The cause of the patient symptoms was due to csf leak.The patient has been back to have surgery, csf leak was determined then repaired and when closing no csf fluid seen.The provided information has been confirmed with the physician.
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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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