Model Number NEU_INS_STIMULATOR |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_lead serial# unknown.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 a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient had a spinal cord stimulator that was implanted in 2019 around halloween.The patient spoke with their manufacturer representative on monday, prior to (b)(6) 2022.The patient had an x-ray done last week and they saw lead placement was not correct, extremely low, and had migrated quite a bit.It was noted another lead on the neck placement was off.The patient had spoken with their healthcare provider (hcp) last week.Their therapy was not doing what it was supposed to and they had a flare up of symptoms mid (b)(6) 2021.
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Manufacturer Narrative
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Concomitant medical products: product id neu_unknown_lead serial# unknown.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 a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient had a spinal cord stimulator that was implanted in 2019 around halloween.The patient spoke with their manufacturer representative on monday, prior to (b)(6) 2022.The patient had an x-ray done last week and they saw lead placement was not correct, extremely low, and had migrated quite a bit.It was noted another lead on the neck placement was off.The patient had spoken with their healthcare provider (hcp) last week.Their therapy was not doing what it was supposed to and they had a flare up of symptoms mid (b)(6) 2021.
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Manufacturer Narrative
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Continuation of d10: product id neu_unknown_lead lot# serial# unknown 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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Search Alerts/Recalls
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