MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Low impedance (2285)
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Patient Problems
Muscle Weakness (1967); Insufficient Information (4580)
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Event Date 10/30/2023 |
Event Type
Injury
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Event Description
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Information was received from a patient (pt) via manufacturer representative (rep) who was implanted with an implantable neurostimulator (ins).It was reported that the lead had migrated and there was a low impedance issue as well.Rep met with the patient in pre op and checked their battery and impedance.It showed that 0-5 were orange.Healthcare provider (hcp) planned on revising their leads and battery.Patient had a loss of stimulation.Once in the or a pre op xray was taken.Compared to the patient's original xray it showed that the paddle did migrate down from the original xray.Hcp attempted to take the paddle out but did not feel safe to continue after having trouble getting the lead out and stopped the surgery.Hcp advised the patient they would meet in the office and come up with a better plan.Issue is ongoing, cause is unknown.
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Manufacturer Narrative
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Other medical products in use during the event include: brand name specify surescan, product id: 977c265, (serial: unknown), product type: 0200-lead, implant date: (b)(6) 2016.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.
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Event Description
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Patient had lost coverage and she met with rep in sept.For programming, and that was when rep noticed impedance issues and eventually it was discovered the lead had moved.During revision surgery on (b)(6), hcp noted that patient had weakness during surgery and the procedure was stopped.
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Manufacturer Narrative
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Continuation of d10: product id 977c265, serial# (b)(6), implanted: (b)(6) 2018, 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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D10: section d information references the main component of the system and other applicable components is the lead.Product id 977c265 lot# serial# (b)(6) implanted: (b)(6) 2018 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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