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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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| Model Number 97714 |
| Device Problems
Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); High impedance (1291); Migration or Expulsion of Device (1395); Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496); Inappropriate/Inadequate Shock/Stimulation (1574); Environmental Compatibility Problem (2929); Insufficient Information (3190); Data Problem (3196)
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| Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554); 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: 977a260, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead, product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2014, product type: lead.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 22-nov-2017, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 22-nov-2017, 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 consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient¿s leads had migrated since (b)(6)2019 and then they migrated more.The patient stated that their healthcare provider (hcp) was aware and they saw their hcp in (b)(6) 2020, and would see them again in (b)(6) 2020.They stead that they were not getting stimulation where they needed it and the patient indicated that they used adaptive stimulation (as).The patient stated that they noticed that when they stand up and start walking, they were not feeling stimulation in either leg.The patient stated that they would start to move their feet and do a ¿low profile¿ jump and then they would feel stimulation.It was indicated that this began about a week ago.The patient also noted that they did have a major surgery again in (b)(6) 2019 which they clarified to be unrelated to their device/therapy.It was reported that the event began in (b)(6) 2019.The patient was redirected to follow-up with their healthcare provider (hcp) and the patient indicated that they have an appointment scheduled for (b)(6) 2020.Additional information was received from the patient via a manufacturer representative (rep) on (b)(6) 2020, reporting that the patient was experiencing pain where the leads were located.It was indicated that it was unknown if there were any factors that contributed to the issue.The patient had a meeting for a device interrogation scheduled for (b)(6) 2020.No interventions were taken at the time of the report and the issue was not yet resolved.It was unknown if surgical intervention was planned and the rep indicated that they would follow-up for more information.Additional information was received from the rep on (b)(6) 2020, reporting that the patient stated that they had a level 5 spinal fusion on (b)(6) 2018 and stated that they started having stimulation issues (lack of coverage) after that surrey, but they indicated that it didn¿t occur right away (patient however couldn¿t provide an exact date issue started, but noted that they saw the assistant neurosurgeon in (b)(6) 2019 and had x-rays done.The rep noted that the most recent x-rays they had for the patient were from (b)(6) 2020, but they didn¿t have any images to compare to,so it was stated that it was unknown if the lead had migrated or not.It was indicated that the x-rays did show that the leads were staggered, but it was unknown if they were originally like that.It was reported that the patient was scheduled to have x-rays done today or tomorrow.The patient indicated that they saw their doctor last month and that was when the physician saw the images and had concerns about he lead migration.The patient also didn¿t know if the leads had possibly migrated even more since that appointment.It was indicated that the patient would be seeing their doctor on (b)(6) to discuss a paddle lead and have x-rays reviewed.Additional information was received from the rep later the same day, reporting that the patient was having issues with their as cutting in and out and that it didn¿t stay consistent for approximately the last 6 weeks.The patient mentioned that the ¿unit was turning off and on¿ and the ¿unit stopped completely¿ during the call and confirmed that they felt their stimulation go away.It was reported that they hadn¿t ever checked their ins with their patient programmer to verify that the ins had turned off.The patient stated that they would go from lying to sitting.They stated that when moving around it showed the mobile position, but there was ¿nothing¿ and it took them walking for a while or tapping their feet to get the stimulation to come back on.The patient stated that while sitting in their office chair today, stimulation was cutting in and out.The rep discovered today that there were high impedances on contacts 0 and 8 and the rep indicated that they were currently trying to program around those impedances issues to attempt to obtain coverage.The rep also indicated that they would turn as off and have the patient try the new programming for a while.Technical services agreed with this since the patient had multiple issues occurring at this time and they suggested reorienting the ins and resetting as amplitudes at a later date.It was also suggested that the patient check their ins with the patient programmer when they lose stimulation sensation to see if the ins is still on or not and to keep a log.The rep reported that connectivity was ¿great¿.The event began in (b)(6) 2019.Additional information was received from the patient on (b)(6) 2020, reporting that the patient met with the rep on (b)(6) 2020 and they noted that their ins was programmed for only one program using as.The patient stated that since the programming, all settings had been ¿wiped out¿ stating ¿all programs were zeroed out¿.The patient stated that ¿ever since (b)(6) 2020 last week at 8:30 in the evening, when the patient was sitting or walking ¿it would read they were in the upright position and the amplitude would change from 1.8 to.8 with out the patient changing anything.It was reported that the rep thought it was the accelerometer and they could not test for that.It was reported that it sounded like the unit might have to be changed, so the patient was going to their hcp who implanted their ins.The patient stated that in the meantime, ¿the thing was doing what it wanted to do¿.They stated that when they were walking it just showed upright.The patient stated that ¿it shocked them from time to time when it made that sudden change.They stated that when they were sitting and walking, the unit changed to lying and left and showed.5 actually while they were sitting and not walking.It was stated that sitting was changed to lying at.5 while i was sitting.Then later that evening at 9:13 while i was walking, it would read upright at 1.5.This was the adaptive stimulation program.When sitting it changed from 1.5 to 1.8.The next day in one setting it went from upright.5 to upright 1.8 to sitting 1.8.Now it was reported it zeroed out everything from program a through f.The patient stated that the rep told them to call in and make sure that this was documented.The patient was wanted to see that a rep could be at their hcp appointment scheduled for (b)(6) 2020 at 3 pm.They indicated that they had already called in to their hcp office and requested that they arrange this, but wanted patient service to reach out to a rep as well.An email was sent to the local rep reiterating the patient¿s device issues reported and issue of the ins changing settings on its own.No further complications were reported/anticipated.
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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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Additional information was received from the health care provider (hcp) via a manufacturer representative on (b)(6) 2020 reporting that the patient was looking for a surgeon.The cause and actions performed were unknown.No further complications were reported.
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Event Description
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The patient reported that after their last spinal surgery in (b)(6) 2018, the patient needed stimulation therapy for their thoracic spine at around t4, and the patient was only getting stimulation up to their buttocks no matter how high they change intensity or rate.When pt went to change their therapy they got stim on the left and right side but not in thoracic spine.Pt doctor said its now at the point if its something with the placement of leads from original surgery.Pt was told by their rep that the leads had slipped and vibrated a little bit.The pts doctor said they might not get therapy in thoracic spine and the doctor wanted the pt to try stim waves which would be another surgery.The patient's implantable neurostimulator was replaced on (b)(6) 2022.The patient had the stimulation turned on, on (b)(6) 2022.Settings were reviewed with the patient, and the patient noted that they do not have access to pulse width or cycling.Pt noted they were not getting good therapy.Pt said they should not have another surgery because this did not work.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2014 explanted: product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6) 2014 explanted: product type lead product id 97715 lot# serial# (b)(6) implanted: explanted: product type implantable neurostimulator 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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