MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97716 |
Device Problems
Break (1069); Unintended Collision (1429); Loss of Data (2903)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 977a260 lot# serial# (b)(4) product type lead product id 977a260 lot# serial# (b)(4) product type information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4) ubd: 23-aug-2025, udi#: (b)(4) ; product id: 977a260, serial/lot #: (b)(4) ubd: 23-aug-2025, udi#: (b)(4).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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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patients balance was horrible. pt has system in back without being turned on for 5 months.Pt had back surgeries.Pt had pain by fusion in spine that was done 6-7 years ago and had damaged nerve.Pt fell on stimulator.Pt said, after the fall, the mdt rep.Prevented the pt from going up any stronger.One of the falls damaged two of the components(8 components total)(patient services specialist understood the fall damaged the pt's leads). pt said at night sometimes they turn the therapy off.Pt said they were not allowed to go any higher in b.Because of fall med.Rep.Put limits on how much they can go up.Last time mdt rep.And pt met the pt said the mdt reps set up a group c.Pt said mdt rep.Did as good as they could.Pt said the therapy in group c covered 90% of the area, but after pt was reprogrammed, pt's feet started freezing.Pt lowered strengthand freezing sensation disappeared.Now pt does not turn up therapy in group c to avoid freezing sensation in feet.Pt said they had 10 surgeries in last 10 years, throat cancer 3 years ago, 3 back surgeries, 1 hip replaced, and an appendices taken out in an emergency.
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Event Description
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Pt called back from number registered re-reporting information previously documented in this case.Pt said they fell 3 times in a month and said one of the falls wiped out their group a.Pt said they met 2 ladies about 3 weeks ago who were going to help them set up b and c (pt mentioned rep harrison).Pt said it worked for awhile but said it was going down their leg.Pt mentioned being in the hcp office friday afternoon and said they had been trying to call "all kinds of people" but was unsure how to get in touch with a rep.Pss redirected pt to hcp for further assistance.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 serial# (b)(6): product type lead product id 977a260 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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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 was received from the patient.It was reported that the patient said they have a balance problem.3 in one month.They are now going to a class learning to improve their balance.The issue was resolved.
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Search Alerts/Recalls
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