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
Burning Sensation (2146); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving unknown drug via an implantable pump for spinal pain.It was reported that the patient will have their pump system explanted on (b)(6) 2022.The reason for the explant was ¿due to failure of therapy, as well as pump site burns and stings¿.The rep clarified that the reason for the explant was due to the therapy being ineffective.There were no issues with the device.The issue was not resolved at the time of report.The patient's weight and medical history was asked and will not be made available.The patient's status at the time of report was asked but unknown.
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Manufacturer Narrative
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Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4 , ubd: 31-aug-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803.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 healthcare provider (hcp) via a company representative (rep) indicated the explant was cancelled after the physician and patient discussed plan of action.The cause and the reason why the explant was cancelled was not made available.
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Event Description
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Additional information was received from a consumer via a company representative on 12-jun-2023 who reported symptom return.There was no environmental, external or patient factors that may have led or contributed to the issue or diagnostics or troubleshooting performed.They planned to explant the infusion system.Surgical intervention did not occur, was planned and scheduled for (b)(6) 2023.The issue was not resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.
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Manufacturer Narrative
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H10: additional information was received indicating that the infusion system was being explanted which is a serious injury, which makes the event reportable now.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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Manufacturer Narrative
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H3 ¿ the pump and catheter were returned for analysis.Analysis of the pump found ¿no anomaly.Analysis of the catheter found ¿catheter body ¿ kink observed.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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