Model Number B35200 |
Device Problems
Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Pain (1994)
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Event Date 04/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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Other relevant device(s) are: product id: b3400060, serial#: (b)(4), implanted: (b)(6) 2021, product type: extension.Product id: b3400060, serial#: (b)(4), implanted: (b)(6) 2021, product type: extension.Other relevant device(s) are: product id: b3400060, serial/lot #: (b)(4), ubd: 27-apr-2023, udi#: (b)(4); product id: b3400060, serial/lot #: (b)(4), ubd: 27-apr-2023, udi#: (b)(4).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 a consumer, via the manufacturer¿s representative (rep), who reported they had pain along the line of both extension wires about one inch below the lead/extension connection.There were no known factors that led to the issue.Impedance testing, programming changes, and turning the device off were performed along with the physician prescribing gabapentin and injecting some lidocaine to help temporarily, but it didn¿t resolve the issue.Due to this surgical intervention was planned for (b)(6) 2022.
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Event Description
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It was reported that patient had lead explanted on (b)(6) 2022, for unknown reason as caller does not yet have the full report.
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Manufacturer Narrative
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Continuation of d10: product id b3400060 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: product type extension product id b3400060 lot# serial# (b)(6) implanted: (b)(6) 2021 explanted: product type extension product id b3301542m lot# serial# (b)(6) implanted: explanted: product type lead 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: b3301542, serial# (b)(6), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: lead.Product id: b3400060, serial# (b)(6) ,implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: extension.Product id: b3400060, serial# (b)(6), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: extension.Product id: b3301542m, serial# (b)(6), product type: lead.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 the manufacturer's representative (rep) who reported that since surgery, the new leads and extensions are not causing the same issues as before, but the patients has been hospitalized due to frequent migraines and dystonia pain (which was common for the patient).There were no issues with the system integrity.The current therapy appears to be helping some of the patient's dystonic issues, but has only been turned on for a couple months now, so they are not optimized yet.Additional information was received from the manufacturer's representative (rep) who reported that the patient underwent new right lead placement on (b)(6).The patient had stage 2 done on(b)(6) followed by the 2nd left lead placement on (b)(6) additional information was received from the manufacturer's representative (rep) who reported that the frequent migraines and dyston ia pain had nothing to do with just the procedure itself.It was stated the patient is complicated and the dystonic flare-ups are unpredictable.The hcp attempted to treat the pain while she was in the hospital but it was difficult.
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Manufacturer Narrative
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Continuation of d10: product id b3301542 serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type lead product id b3400060 serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type extension product id b3400060 serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type extension product id b3301542m serial# (b)(6) implanted: (b)(6) 2021 explanted: (b)(6) 2022 product type lead.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 the manufacturer's representative (rep) who reported that the revision was performed due to poor lead placement with the first dbs procedure.The patient has a history of headaches but did experience worsening of them after the revision.The patient is seeing a headache specialist.The neurologist believes the dbs and headaches are unrelated to each other.When the dbs is off, the headaches do not improve.
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Search Alerts/Recalls
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