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Model Number 105-7100-060 |
Device Problems
Migration or Expulsion of Device (1395); Sparking (2595); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Inflammation (1932); Undesired Nerve Stimulation (1980); Electric Shock (2554); Foreign Body In Patient (2687)
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Event Date 10/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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B3.Month and year are valid for earliest publication date which is used for reported event date.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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Jimenez, a.R., florell, s.R., <(>&<)> donigan, j.M.(2021).Encountering ethylene vinyl alcohol in dimethyl sulfoxide embolization material during electrodesiccation and curettage.Dermatologic surgery¿: official publication for american society for dermatologic surgery [et al.], 47(10), 1405¿1406.Https://doi.Org/10.1097/dss.0000000000003157 medtronic review of the literature article found a case review of an 87-year-old male patient presented to undergo ed<(>&<)>c of a bowenoid actinic keratosis/evolving squamous cell carcinoma (scc) in situ located on the left parietal scalp.The patient was also referred to undergo mohs micrographic surgery (mms) for a 20 3 25 mm biopsy-proven invasive squamous cell carcinoma with bowenoid features on the left frontal scalp.It was reported that, "on initiation of curettage of the left parietal scalp lesion, a hard black material was encountered at the base that could not be curetted and sparked on contact with the electrode tip during electrodesiccation." since electrodesiccation and curettage (ed <(>&<)>c) could not be completed and due to the close proximity to the left frontal scalp scc being treated with mms, it was decided to also treat the tumor with mms taken toa depth below the foreign material.The patient reported undergoing an embolization procedure to treat an arteriovenous fistula (avf) 4 years prior and review of the patient's medical record found that embolization had been completed with onyx-18.The mms procedure was completed successfully with no residual carcinoma observed.Monopolar electrocautery was used during the repair with no further encounter with onyx material.The authors noted the sparking was likely due to the combustibility of the onyx.And that chronic inflammation in the patient vessel may have weakened the vessel wall, allowing the onyx extrusion into the patient's superficial dermis.
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Manufacturer Narrative
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Correction- added ime e2104.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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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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