MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Unintended Collision (1429); Energy Output Problem (1431); Insufficient Information (3190)
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Patient Problems
Chest Pain (1776); Pain (1994); Urinary Tract Infection (2120); Numbness (2415); Ambulation Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2020 |
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.It was reported that the reason for call was the patient's pain stim was malfunctioning and they were in a crisis and they were trying to shut stim off today.The patient stated she accidentally pressed the wrong button on the recharger and got increased stimulation.Patient reports for the last 12 days she was having symptoms and she went to the er last night.They were having tightness around chest, her legs were dragging, and legs were not connected to her brain and her legs are only moving because of muscle memory.The patient reported that normally she had a lot of bladder pain and now she had no pain and she was numb from the waist down.Patient reported she was having problem emptying her bladder even though she had a remote and thought there was an infection.The patient was assisted with using the recharger to turn therapy off.The troubleshooting steps that were taken on the call resolved the issue.The patient believed the symptoms she was having was related to her pain stim therapy.Patient stated they had been falling a lot since sept 2020.It was reviewed falls or trauma could cause device to shift or move and change how therapy is helping and recommend patient consult with their healthcare provider.Since turning off therapy off while on the phone the patient was feeling relief.Patient stated she was trying to turn her of stimulator off with her recharger and she was not sure how to turn stim off and she didn't have her glasses on and accidentally press two buttons on the recharger and got an increased stimulation.The patient was asked to use the programmer and the programmer showed batteries needed to be replaced.It was reviewed that once the batteries are replaced patient could decrease stimulation with programmer without turning therapy on.The patient was asked to connect with recharger and patient is getting all coupling bars and therapy is on.Patient was assisted with turning therapy off with the recharger.Patient states symptoms seems much better with pain stim off.It was noted that after 12 hours since the ins was shut off and the patient was already noticing an improvement in their symptoms.
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Manufacturer Narrative
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Continuation of d10: product id: 977a260, serial# (b)(6), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(6), implanted: (b)(6) 2014, 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 from the patient.The reason for call was pt stated that "there is not a dr out there who is willing to help me." pt stated that the device is stuck and will not come out and the leads are resting on their femoral nerves, and they won't come out either.Pt stated that "this has been there way too long, and it's out of everybody's skill set, and they keep sending me to different drs." pt stated that the drs that don't take their insurance will do it, but the drs who do take their insurance won't do it.Pt stated that "i can't be the only one that this has happened to." pt stated that they have been to the best hospitals in the state.Ps asked the pt regarding event date and pt stated that they knew that there was a problem that they were getting unfavorable stimulation.Pt stated having a lot of numbness and difficulties and the dr suspected it was that and "cut them open" on march 5th, and thought that implant was going to slide right out and that the leads would follow and they put pt under a fluoroscope and it looked like the leads weren't moving and the "battery pack" still did not come out but it was sometime well before march 5th where they noticed a problem with the device and leads.
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Manufacturer Narrative
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Continuation of d10: product id: 977a260, serial #: (b)(6), implanted: (b)(6) 2014, explanted: product type: lead.Product id: 977a260, serial #: (b)(6), implanted: (b)(6) 2014, explanted: 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.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)2014 explanted: (b)(6)2021 product type lead product id 977a260 lot# serial# (b)(6) implanted: (b)(6)2014 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 received from a healthcare provider.It was reported that the patient felt that their ins was not working and had been causing the patient chronic pain.The ins was malfunctioning.They saw another doctor who attempted to remove it but could not and then they sought multiple opinions and were unable to find anyone willing to take the ins out.The healthcare provider was able to remove the patient's ins and leads.There were no complications.
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Manufacturer Narrative
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H3: product id# 97714, serial# (b)(6) was returned for analysis.Analysis determined that the implantable neurostimulator (ins) was permanently damaged due to overdischarge.Product id 977a260, serial# (b)(6) was returned for analysis.Analysis identified that the lead was returned segmented; however electrical testing of the returned segment(s) determined that continuity was complete and there were no electrical shorts between the circuits.Product id 977a260, serial# (b)(6) was returned for analysis.Analysis identified that the #5 conductor was broken in the distal end of the 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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