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Model Number 97725 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Rash (2033); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
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Event Date 03/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_lead, serial#: unknown, explanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was trialing a spinal cord stimulation system.It was reported that the patient was trialing a spinal cord stimulation system.On (b)(6) 2021, the patient reported itching under surgery bandages.There was an unscheduled emergency room visit on (b)(6) 2021.There was redness involving all area under tegaderm and gauze.An allergic reaction around the lumbar site was diagnosed.The spinal cord stimulation leads were removed in tact on (b)(6)2021, and the patient was prescribed polysporin and keflex. skin irritation was still present on (b)(6) 2021 at their office visit.The patient denied a rash as of (b)(6) 2021, and it was noted that this event was resolved.
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Manufacturer Narrative
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Continuation of d10: product id 977d260 lot# serial# unknown explanted: (b)(6)2021 product type screening device 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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Continuation of d10: product id 977d260; serial# unknown; explanted: (b)(6) 2021; product type screening device.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 multiple sources (healthcare provider, clinical study) reporting that the patient had skin irritation and that they have been having damp yellow discolored bandages when they changed their bandages.They endorsed pruritis to the area of their surgical site ed visit (b)(6) 2021.The wound was checked and headache referrer action date was (b)(6) 2021.It was indicated that the event resulted in an emergency room visit/unscheduled clinic/office visit.It was indicated that the issue was not related to the device/therapy but was related to the implant procedure/surgery/anesthesia.Additional information was later indicated that the clinical diagnosis was contact dermatitis of their lumbar spine.Medications-antibiotics and steroid cream was administered.On (b)(6) 2021 pictures were collected of the site.On (b)(6) 2021 the patient continued to have irregularly shaped rash over their lumbar spine that was present with spinal cord stimulation trial.The skin however appeared to be less erythematous and appeared to be pigmented in area of old.The areas of hyperpigmentation appeared to be slightly warmer to touch than the other areas of the skin on (b)(6) 2021.There was a pale shadow of the lumbar rash.As of (b)(6) 2021 the issue appeared to resolve without sequelae.
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Search Alerts/Recalls
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