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Model Number 97715 |
Device Problems
Migration or Expulsion of Device (1395); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Paralysis (1997); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 977c165, serial#: (b)(4), implanted: (b)(6) 2021, product type: lead.Other relevant device(s) are: product id: 977c165, serial/lot #: (b)(4), ubd: 26-jun-2025, 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 manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that patient is not receiving effective relief with her system.The cause was unknown, patient states she has been careful since implant. we have been working with her to try additional groups with her controller at home, but she states no such luck. x-ray was taken, time and date unknown which shows a slight migration upwards with the paddle lead.Initially the lead was placed higher than we wanted so coverage out of the get-go was not as good.We are recommending an appointment with the patient and physician to discuss a possible lead replacement, going lower with the placement into t8 and not t7.It was unknown if the surgical intervention was planned.
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Event Description
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Additional information was received from the manufacturer representative (rep).It was reported that the actions/interventions taken was a lead revision, although apparently symptoms were trending towards resolve on their own.The paralysis and hematoma have resolved to the rep's knowledge.
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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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Event Description
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Additional information from the rep indicated that lead was placed higher than what was placed in the trial, but the patient was doing well with the programming they had placed her on until she wasn¿t doing well and then x-ray determined their was a migration.Additional information from the rep on 2022-02-24 indicated that the patient was going back in for urgent procedure related concerns post-revision.Caller states the pt had a lead revision today and noted that after the revision, the pt had leg paralysis and the hcp(s) believe the pt may have a hematoma.The pt is now being brought in for a procedure to potentially address this.
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Manufacturer Narrative
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Continuation of d10: product id 977c165 serial# (b)(6) implanted: (b)(6) 2021 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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