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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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| Model Number 97714 |
| Device Problems
Electromagnetic Interference (1194); High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Burning Sensation (2146); Numbness (2415); Electric Shock (2554); Insufficient Information (4580)
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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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The reason for call was pt reported that for about the last two years, they have had serious problems with their spine, mobility, and ins.Pt shared that they had been off health insurance for some time, and now recently got on health insurance again.Pt saw a surgeon recently and did an mri of their lumbar spine yesterday and now has to wait a few weeks for the results.Pt inquired whether mdt could do something in the meantime to check their ins and leads, as the pt suspects there may be something wrong.Pt said that it is painful for them to use the stimulator and painful for them not to use the stimulator.Pt said they aren't sure if they are helping or hurting themselves.Pt reported they feel excruciating pain from their mid-back down, burning and numbness to the bottom of their feet and toes; pt stated that because of this, they couldn't drive to hcp to get a pain injection.Pt said they have severe muscle wasting and it has gotten worse and worse.Last month, pt was attending physical therapy but lost control of their bowels the day after a therapy session, so they were removed from physical therapy.Pt was fearful that something bad has happened with their back and they do not want to be paralyzed.Pt mentioned they are getting a cervical mri in a couple weeks.Pss emailed field reps to contact the pt.Redirected caller: other (document in note) additional information received.Patient reported lumbar/cervical and thoracic mri is probably needed.Patient does know exact cause.Health care provider talking to patient about malfunctioning and probably needs to be replaced.Patient reported they've been fighting this issue for over 2 years.Issue not resolved.Patient reported needing help with stimulator before it paralyzes patient.Patient reported having mid spine down extreme pain, numbness and burning.Patient reported it was hurting them.Patient reported being electrocuted in heart/breast/ribs and belly.
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Event Description
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Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reported that they have had pain going on for 3.5 years and the pain gets worse and worse.Pt said they get numbing and burning in their whole lower half of their body and heart, chest and lungs.Pt also said they have electrical issues everywhere and this worsens while they are walking and in a straight up position.Pt said that they were out in public in august or september and they had severe pain and they went to the er and they pushed, pushed, pushed for an x-ray and they found the lead had migrated into the thoracic.Pt said they have an upcoming mri of this in two or three weeks.Pt said they are seeing a neurologist and they are helping them with a diagnosis for all of their health issues and the pt said that they are thinking ms right now.Pt also said that they do know that they are going to need the stimulator replaced or get the leadsor wires fixed or something.Pt also said on the call that they need their stimulator to help with their pain so they are doing more research to figure out what to do.The reason for call was pt reported that about 9 months to a year ago they had an mri of lumbar and after the mri they hurt for days.Pt mentioned having many of mris over the years an said mri's don't hurt.Pt said this mri hurt their whole body, back legs and everything.Pt said the mri hurt really bad and now they have an upcoming mri of their thoracic for their migrated lead wire.Pt said the doctor gave them a valium prescription so they are going to try that.On (b)(6) 2022, the patient was seen by a healthcare professional because she was feeling a sensation in her chest and upper body while using the stimulator.She had an mri done in 2021 that showed one of her leads had moved slightly.The patient had fallen before the 2021 mri, so she thinks that could have led to the lead moving and the cause of the sensation in her chest and upper body.Her stimulator was interrogated on (b)(6) 2022, and it was found that on the lead that had moved, electrodes 9-13 were showing impedance values greater than 10,000 ohms.Nearly every program was using those electrodes.The health care professional had the patient lie down and turned on the "good" lead without the "bad" one that had impedances of greater than 10,000 ohms, and the patient did not report the sensation.When they utilized the "bad" lead without the "good", she would feel the sensation.The patient's stimulator was reprogrammed to not utilize the 8-15 lead.They were able to get coverage in her low back.No surgical intervention was planned or performed to resolve the issue.Additional information received regarding manufacturer report # 3004209178-2022-02483 will be submitted as a supplemental to this re port.
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Manufacturer Narrative
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Continuation of d10: product id 977a260 serial# (b)(6) implanted: (b)(6) 2016 product type lead product id 977a260 serial# (b)(6) implanted: (b)(6) 2016 product type lead h10.Additional information received regarding manufacturer report # 3004209178-2022-02483 will be submitted as a supplemental to this report.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 977a260 lot# serial# (b)(6) implanted: (b)(6)2016 explanted: product type lead product id 977a260 lot# serial#(b)(6) implanted: (b)(6)2016 explanted: product type lead **the lead explant was reported under reg report # 3004209178-2022-12423.All additional information related to this event will be provided as a supplemental report under this regulatory report instead.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 on (b)(6), 2022.It was reported the pt needed an emergency mri but the pt had not used their neurostimulator (ins) since may (charging ins one other time since).Caller stated the patient had been transported today to the er by ambulance.Caller stated when patient is putting their remote to it to activate mri mode it indicated the ins battery had no charge.Pt commented that they did not know that the ins had depleted.Caller <(>&<)> pt wanted to know if patient services (pss) could put the ins in mri mode over the phone.Pt stated they had a mri in the past and this one was to scan the brain.Pss provided the pt with the number for the national answering services to schedule an appointment with a manufacturer representative (rep).The pt reported their implanting physician was no longer taking the patient's insurance, so the pt had followed up with a different neurologist (for all the issues in their body) who talked about taking ins out.Caller said the pt had met with a rep at the other neurologist but did not know the name of the rep since they had not been seen in awhile (pt confirmed they had meet with a rep more than once).Pt joined call saying they are seeing a ms neurologist who sent them to a neurosurgeon who said they would take the scs out if pt agreed to a pain pump in their belly which they refused.Pt said they want the scs ins fixed without being on pain medication so they could get on with their life.Pt said a rep had shut one lead off which was misfiring saying they have been needing the mri for several years.A healthcare provider reported that when the patient tries to connect to the ins with the patient remote, the remote says that the ins has no battery or it it is low.The patient claimed that the ins hasn't been used for months because they had lead issues.Troubleshooting was not required.The issue was not resolved through troubleshooting.The hcp also reported that the patient had indicated that one of the leads had to be removed but the caller did not have other details.Troubleshooting was not required.The issue was not resolved through troubleshooting.
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