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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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| Model Number 97715 |
| Device Problems
High impedance (1291); Energy Output Problem (1431); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Charging Problem (2892); Patient Device Interaction Problem (4001)
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| Patient Problems
Discomfort (2330); Electric Shock (2554)
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| Event Date 06/04/2020 |
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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 a consumer via a manufacturing representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported that the patient said they feel like they are getting a shocking sensation in the are where the ins is implanted.The issue occurs when the patient is sitting in a recliner chair at home.The issue does not occur while sitting in the passenger seat of a car.If the patient stands up while the shocking occurs, then the sensation stops.The rep had the patient turn the stimulator off while the shocking occurred, and the shocking stopped.The rep tried to reprogram the patient to different settings, and it did not alleviate the issue.The rep inspected the pocket area and the ins appears to be canted and sitting at a diagonal position.The rep ran an impedance check and contacts 0, 1, 6, 7, and 8 all show high impedances and to avoid those contacts.No actions and interventions have been taken at this time.The patient will see their healthcare provider (hcp) and discuss what they want to do.The patient has no knowledge of what would have led to this event.The issue started happening two and a half weeks ago.No further complications were reported or are anticipated.
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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.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 rep and it was reported that the adaptive stim feature was not on initially, but was turned on to try and see if it would help.There was no change when it was turned on.No further complications were reported or anticipated.
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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 rep on july 2, 2020.They reported they discussed the following information with the physician.It was reported that the cause of the event was not determined, but it seems it was possibly due to the battery becoming canted inside the ins pocket.The physician was planning on doing a pocket revision, so the issue has not yet been resolved.No further complications were reported or anticipated.
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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 received from the rep indicated that the device still remains implanted at this time.They stated that after the device has been explanted, they will send it back for return.The rep noted that at this time, the physician¿s account has not given them a timeline on when the patient¿s device is to be explanted.
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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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The patient had a pocket revision performed in (b)(6) 2020.The patient reported via a manufacturer representative that they were feeling a shocking sensation in the implantable neurostimulator pocket, to her side, and her kidney.The patient said that the sensation occurs even if the implantable neurostimulator is off.An impedance test was performed on the day of the report, and it was noted that contacts 1, 6, and 7 were orange, and 13, 14, and 15 are red.Reprogramming was going to be performed on viable contacts (in regards to impedance values) to try and resolve the shocking sensation.
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Event Description
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Cause of shocking sensation has not been determined.Rep reported reprogramming has not resolved the shocking sensation.
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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 received.Mdt called because patient (pt) is still experiencing the same issue that started 2 months after implant.Pt feels shocking sensation in hip and groin area.The sensation intermittently ramps up in intensity.Pt said she does get some pain relief from the therapy but the issue is increasing.Pt said when she charges she "feels it charging the battery through her skin." pt reports she has had the ins off for up to two weeks and still feels the sensation.Rep said he is meeting the pt today.Caller, rep was with pt in clinic.Reviewed previously reported events of discomfort and shocking and jolting in hips, back and pelvic area (pt noted they can't lie on their right side due to discomfort - ins on left side).Pt gets this sensation persistently with stim on and off.A pocket revision was done in approximately july 2021 of 97715 to try to address the discomfort but this didn't resolve the issue.At that time the ins was moved more medially toward the spine but it was kept on the left side.Pt still getting therapy benefit in arms and hands (cervical lead) but feels like pain relief has lessened gradually over time but pt couldn't put any timing on it.Pt charges a little more frequently than she used to but her charge duration is the same (per recharge stats, pt charged twice in feb, once in march, twice in april and twice in may.Pt starts at 40 or 50% and fully charges ins.All of pts recharge sessions show excellent recharge quality.) reviewed impedances that were showing open circuits already mentioned, namely 1,6,7,10,11,13,14,15 which were all 35,000 ohms or higher).None of these are programmed.There is no concern about rsd at the pocket site.Palpation by hcp during visit today created an extra sensation of jolting for pt.There is concern about ins malfunction causing the shocking since pt didn't have this issue with their prior ins.Tss reviewed consideration to move ins location and/or replace ins due to continuing discomfort.Tss reviewed there was no clear evidence of an ins malfunction but it was hcp decision on how they want to proceed.Caller is going to try some reprogramming to try to enhance therapy benefit for the pt in the short term.
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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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The rep called back with patient(pt) in clinic.Rep reiterated details documented below.Rep mentioned the pt had a shocking sensation periodically and pt said they tried to sit and hunch over in a certain way to keep their tissue loose so the muscles did not tighten around the ins pocket site when the pt stood up.Rep said the pt told them when the muscles tightened when they stood up, the pt experienced shocking sensations in various positions throughout the day.Rep had tried turning therapy off for about a week or so, but the shocking sensation continued.Rep shared high impedance values with reference electrode #0 - 1 at 23970, 6, - 34410, 7 at 34010, 10 at 23720, 11 at 40, 000, 13 at 40, 000, 14 at 40, 000, and 15 at 40, 000.Technical services (tss) discussed getting imaging of implant site and discussed possibility of ins positioning possibly causing sensation.Tss and rep discussed possibility of lead being pulled out of connector block on ins.Rep mentioned they had programmed around impedance values, but shocking sensation had not resolved.
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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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