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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A patient was treated with a venaseal closure system to treat the great saphenous vein (gsv).The lumen was not flushed prior to use.The ifu was followed during preparation, procedure, post-procedure.Local anesthesia was used.Transducer compression used.The procedure was completed normally with venaseal.25cm treated.The vein closed.It is reported that skin irritation or burn occurred.Patient experienced a generalized rash treated with hydrocortisone cream prescribed by the doctor.The patient did not complain of pain during active treatment.The irritation/burn was noted at the follow up visit (b)(6).The irritation/burn is resolved as of (b)(6), the rash resolved.The patient complained about feeling ¿elephant sitting on chest¿ on july 23rd that resolved without further treatment.
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