MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Pocket Stimulation (1463); Patient Device Interaction Problem (4001)
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Patient Problems
Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271); Malaise (2359)
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Event Date 03/16/2020 |
Event Type
malfunction
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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 regarding a patient who is implanted with a neurostimulator.It was reported that the patient was following the manual for the charger directions, but she could not seem to get it where it needs to be.The patient clarified this to mean that the implantable neurostimulator is good, and that she was trying to charge the patient controller.It was reviewed that the green light was flashing on top of the controller and the ac adapter had the green light illuminated when plugged into the wall.The patient controller battery was at 100% charge and the implantable neurostimulator was at 90% charge.The patient then indicated that she was trying to get the stimulator to work.She noted that she has not been getting therapeutic relief from the implantable neurostimulator since over the weekend ((b)(6) 2020).The patient indicated that her therapy was on and that she was trying to get it to work like it should.The patient was trying to change the group.The group was currently on group a.When patient services was walking the patient through switching groups, it was discovered that the stimulation was off.The patient was able to turn the stimulation on and then change the group.The patient noted having groups a, b, and c.The patient wanted to have group a on and was guided in setting to group a, but then the patient stated that it went to group b and did not even touch it after pressing a.The patient was able to switch back to group a.The patient was having difficulty understanding and utilizing the equipment.The patient asked if she should feel something like a vibration.The patient was not feeling the stimulation.The patient¿s current setting as at 2.8 milliamps, and she noted that it maybe was not set high enough for her liking to feel stimulation.The patient was going to continue to work with the external equipment and the implantable neurostimulator settings to find the correct stimulation settings.On (b)(6) 2020, the patient noted that she tried groups a and b previously and did not feel stimulation, but this was likely due to her using the patient controller incorrectly.The patient had stopped taking her oral medication.Due to the pain, she used a cold pack on (b)(6) 2020.When she used the cold pack, she felt a tingly sensation down her leg.The patient indicated that this concerned her and she discontinued using the cold pack.The patient was able to verify on the patient controller that she was on group c with stimulation on and at 4.3 milliamps.The patient confirmed that she felt stimulation comfortably in her right thigh.The patient noted that she had pain in her back and right leg and indicated that through the education, she felt comfortable using the patient controller on her own.Additional information was received from the patient.It was reported that the patient had been in pain for a while causing her legs to be weak.She also felt a tingle from her waist down.The patient contacted her hcp and they took an x-ray of her back, but she hasn't heard back regarding the results.The stimulation was on group b and the tingle feeling was causing the pain and leg weakness.The patient called back with a continuation of pain noting it was terrible, excruciating, and she had been sick from the pain.The device was on group b at 3.6 and the patient noted some feeling and some tingling.The stim was increased to 4.2, but the tingling was too high so the patient decreased back down to 3.6.The tingling was noted to be across the lumbar back/spine and down her legs.Group a was tried at 3.2, and the tingling was felt by the battery and down her right leg.The settings were decreased to 3.0 and tingling was felt, but it was not too much.X-ray results were not yet available.No further complications were reported.
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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 received from the patient reported that she had an appointment for (b)(6).The patient repeated the information about the therapy making her ill, weak and nervous and her back hurting where the implant was located.Troubleshooting assisted with turning the therapy off with controller and it was noted that the implant was orange and the controller was 70% charged.The patient was directed to follow-up with their healthcare provider for the next steps.
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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 patient reporting that they were having horrific pain on the lumbar spine area near the implant area and they turned the stimulation up and down and that was not making a difference with the pain.The patient stated that their healthcare provider (hcp) office was 50 miles away.Patient services confirmed the patient did not have any recent falls or traumas.The patient did note they had a fall in march but stated that the healthcare provider (hcp) did an x-ray and stated everything was ok.Patient services recommended that the patient turn their therapy off to see if that helped with their pain.The rep¿s role was reviewed and it was recommended that the patient follow-up with their hcp for next steps.The patient asked if they could use an ice pack and information was reviewed with the patient.The event occurred on (b)(6) 2020.No further complications were reported/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 patient.It was reported that the circumstances that led to the tingling in the patient's legs was a change to device programming.No device issues were found.It was reported the clinician helped the patient when they called.No further complications were reported.
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Search Alerts/Recalls
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