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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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| Model Number 37612 |
| Device Problems
Break (1069); High impedance (1291); Unintended Collision (1429); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Vibration (1674); Patient Device Interaction Problem (4001)
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| Patient Problems
Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991); Complaint, Ill-Defined (2331); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 09/23/2020 |
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Event Type
Injury
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Manufacturer Narrative
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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 the manufacturer¿s representative (rep) who reported the consumer had a replacement on (b)(6) 2019 where two implantable neurostimulators (ins) were replaced and the left chest extension was routed to the right chest.Last night, the consumer had a back spasm, not associated with the deep brain stimulation (dbs) and the back spasm propelled them forward.The consumer didn't hit their head but did jerk their shoulders back and their chest may have hit the floor where the device was, although their hands were in front of them.Following that the consumer experienced paresthesia/jolts/shocking sensation down the right arm, right leg, left face, left hand, and left sided teeth.The consumer went to the emergency room and the rep was called around 1 a.M.The rep was with the consumer today and noted there were no issues with symptom control midline tremor, head, and bilateral hand tremor, but when the consumer lifted their shirt over their lead they experienced a jolt.The consumer had bilateral vim placement and was programmed on c2 on left vim.The rep went ahead and turned the consumer¿s programming down to 0.6 to 0.8 try and avoid the jolts/paresthesia which helped but didn't resolve the symptoms.In addition, the rep was going to send the impedance report done on (b)(6) to be compared against what was being seen currently.All results were normal expect the left vim on 0 showed 2,265 in (b)(6).Impedance results from (b)(6) were normal on the left vim in bipolar, but in monopolar 3 was 2,597, 1 was 2,571, and 0 was 3,385.The right-side vim were all normal.Following this the rep palpated the device during testing and results were all normal for the left vim (lowering the impedances) except 0 was 3,321 on monopolar settings.There was no change in electrode impedance results when the consumer had their right arm extended outward and back from their body trying to put stress on the system.The rep noted comparing impedance results from august to current time the electrode and therapy impedances there were significant differences (therapy impedances were normal).However, there were not significant electrode impedance results with contact 2 on the left brain where they were programmed regardless of palpating on the device and the right arm being stretched outward and back as to put stress on the system.Unfortunately, this testing was limited to only fractions of seconds at a time when it was tested, so it limited what was seen.The therapy impedances were done at a lower voltage as was the electrode impedance.There was also an x-ray of the chest from (b)(4) they were going to compare with an x-ray and head ct from today.The consumer was a6so going to take a diary and note any movements that caused the sensations.
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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 a consumer via a manufacturer representative (rep) reporting that when they palpate the extension plug in the location (left body behind ear), they almost always get a strong jolt in the inner chest side of their right arm.It was suggested to run testing in position that the patient is describing to see if they elicit any shorts.The rep stated they are looking at either replacing just the ins to the percept or ins/extensions.It was reviewed it would seem unlikely that the issue would be resolved by replacing the ins.They did not believe there to be any specific allegation against charging.
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Event Description
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The patient reported that over the weekend, the system seems to have times when it is working better than other times. there is no time that it is working with typical proficiency. they can hear the electric current in their left ear.They do not hear current passing by the right ear.Pt has avoided charging the battery over concerns that the electricity "could go rogue and jump to the wires" and wonders if that is even a possibility or just his imagination. if he turns up the system, he receives a modicum of relief from the dystonia but experience surges.If he turns down the power, his neck knots up.Rep advised pt to continue charging as there should be no concern about doing so.
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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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Impedances were run while palpating the device to try and troubleshoot.The cause of the jolt was unknown.In intervention will take place to further troubleshoot but no date was planned.
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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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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 stating there was potential fracture concerns due to the monopolar results.Impedances were high.The patient had their ins replaced with a percept.When the therapy was turned on, the patient felt much more comfortable.
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Event Description
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Additional information was received from a manufacturer representative (rep) reporting it was not confirmed there was a fracture.The institution has the explanted ins and will dispose of the device.Per today's interrogation (10/14), the patient's baseline electrode impedance, post-back spasm fall, were back today.Left monopolar impedance check showed 0 at 2,838, 1 at 2,392, and 3 at 2,515.However, there were no uncomfortable jotls/parasthesia since the replacement in any body position on the right or left side of the body.The tremor ¿breakthrough¿ (the patient is quoting 75% efficacy head tremor, 95% for right hand, 70% for left hand) and tightness in their neck are on the left side, not the right.They rep helped increase the current allowance for the patient.They increased the right ventral intermediate nucleus (vim) to 3.7ma and within 5 minutes, the head tremor improved another 10%, neck loosened up and felt better, left hand tremor significantly improved to 90%, and no speech or other side effects.The patient skipped their last botox injections in their neck due to covid, hence, they have not had botox for 5 months.The patient has upcoming appointment and hopes that after, they may be able to come down in dbs amplitude.The patient has a 0.6ma increase opportunity on each side.
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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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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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Surgery was performed today - removed entire system except percept ipg.Implanted new leads and extensions and tunneled to right chest ipg.This resolved high impedances that were noted on (b)(6) in pre op on left lead wire.All impedances are normal with hope that shocking will not occur again.
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Manufacturer Narrative
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Continuation of d10: product id: b35200, serial#: (b)(6), implanted: (b)(6) 2020, product type: implantable neurostimulator; product id: 3389s-40, lot#: va04syk, implanted: (b)(6) 2013, explanted: (b)(6) 2021, product type: lead; product id: 3708660, serial#: (b)(6), implanted: (b)(6) 2013, explanted: (b)(6) 2021, product type: extension; product id: 3708660, serial#: (b)(6), implanted: (b)(6) 2013, explanted: (b)(6) 2021, product type: extension; product id: 3389s-40, lot#: va04syk, implanted: (b)(6) 2013, explanted: (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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Manufacturer Narrative
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Continuation of d10: product id 3389s-40 lot# va04syk implanted: (b)(6) 2013 explanted: (b)(6) 2021 product type lead product id 3708660 serial# (b)(6) implanted: (b)(6) 2013 explanted: (b)(6) 2021 product type extension product id 3708660 serial# (b)(6) implanted: (b)(6) 2013 explanted: (b)(6) 2021 product type extension product id 3389s-40 lot# va04syk implanted: (b)(6) 2013 explanted: (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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Event Description
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Additional information was received.It was reported the patient said they did something that caused his lead wire to break in (b)(6) 2020 and said his battery was pulsating/jumping.The patient had revision and eventually a new neurostimulator.
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Search Alerts/Recalls
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