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Model Number SP-101 |
Device Problem
Biocompatibility (2886)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 06/01/2022 |
Event Type
Injury
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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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A physician used a venaseal closure system for treatment of the great saphenous vein (gsv).The ifu was followed. no challenges or deviations related to the procedure, the catheter tip was 5cm caudal to sfj.Systemic urticaria developed in the patient approximately 1 month post procedure. prednisone 1 mg were administered at onset over a period of 1 month.The symptoms subsided within 2 weeks after the start of treatment, but since the symptoms recurred, steroids were prescribed.It is currently under control, but concerned about recurrence.Removing the product is being considered in the event of a recurrence.The patient is under observation.
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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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A physician used a venaseal closure system for treatment of the great saphenous vein (gsv) ((b)(6) 2022).The ifu was followed. no challenges or deviations related to the procedure, the catheter tip was 5cm caudal to sfj.Systemic urticaria developed in the patient approximately 1 month post procedure. prednisone 1 mg intravenous steroids were administered at onset over a period of 1 month.The symptoms subsided within 2 weeks after the start of treatment, but since the symptoms recurred, steroids were prescribed.It is currently under control, but concerned about recurrence.Removing the product is being considered in the event of a recurrence.The patient is under observation.
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Search Alerts/Recalls
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