MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Fluid/Blood Leak (1250); Material Integrity Problem (2978)
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Patient Problems
Headache (1880); Nausea (1970); Paralysis (1997); Shaking/Tremors (2515); Ambulation Difficulties (2544); Convulsion/Seizure (4406); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 03-aug-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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On (b)(6) 2022 (b)(4) (rep, hcp): multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving dilaudid (hydromorphone) (4.0 mg/ml at 0.8 mg day) via an implantable pump for malignant pain, non-malignant pain, spine/back, and chronic low back pain.It was reported that patient had withdrawal symptoms and suspected cerebra spinal fluid (csf) coming from the pocket, seemed to be leaking around the hub.Factors that have led to the issue was a damaged proximal hub.The pump segment was replaced with a 8784.The issue was resolved.The patient status.
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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 consumer (con) reported that the patient had their pump replaced due to normal eos (end of service) on (b)(6) 2022.The patient reported that starting that saturday or sunday, the patient started to have seizures and was shaking really bad.The patient reported that they were taken to the er (emergency room) and it was found out that the pump was not correctly connected and was leaking saline into the patient's body.The patient also reported that this had also abruptly stopped their pain medication as welland the patient went through severe withdrawals.The patient additionally reported that on 2022-may-30 they had to go in for another surgery which caused the patient to be paralyzed for 2.5 days where the patient was not able to move their arms or legs.The patient reported that they stayed in the hospital for 4 days and then was sent to rehabilitation where they staye d for another 11 days.The patient reported that they got home yesterday ((b)(6) 2022) and was feeling better; however, their legs are still a bit wobbly and balance was not the best.
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Manufacturer Narrative
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H3 ¿ analysis of the catheter found ¿catheter body ¿ damage to transition tube¿.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 the consumer (con) reported that on (b)(6) 2022, the patient went to the er (emergency room) due to severe headaches.The patient spent 35 days in the hospital with excruciating headaches.They did a ct (computed tomography) scan and wanted to do an mri (magnetic resonance imaging) but did not because the patient has a pump.The patient denied falls or trauma.The patient went home on (b)(6) 2022 but the patient was still having severe headaches and not eating due to nausea.
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Manufacturer Narrative
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Continuation of d10: product id 8784, serial# (b)(6), implanted: (b)(6) 2022, product type: catheter.Product id 8780, serial# (b)(6), implanted: (b)(6) 2015, 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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Search Alerts/Recalls
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