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| Model Number 8637-20 |
| Device Problems
Pumping Stopped (1503); Material Integrity Problem (2978)
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| Patient Problems
Itching Sensation (1943); Muscle Spasm(s) (1966); Muscle Weakness (1967); Overdose (1988); Twitching (2172); Dizziness (2194); Dysphasia (2195); Therapeutic Response, Decreased (2271); Anxiety (2328); Distress (2329); Complaint, Ill-Defined (2331); Toxicity (2333); Malaise (2359); Sweating (2444); Diaphoresis (2452); Ambulation Difficulties (2544); Cognitive Changes (2551); Lethargy (2560); No Code Available (3191); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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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 and a healthcare professional (hcp) via a company representative regarding a patient receiving morphine at 5 mg/day via an implanted pump.The patient¿s medical history included a jumping accident in the military that took out both his hips requiring complete replacements at different times.He also had severe nerve damage to his spine, many injuries, and arthritis.He stated that he had himself in ¿self-physical therapy¿ because he knew if he stopped or didn¿t do something, he was going to feel much older than he was, so he took care of himself.He had been told if he didn¿t keep moving, he would begin to hurt, and it would not be good for him.He did not drink or smoke.On (b)(6) 2020 the patient reported that he was hearing the pump alarm every 15 minutes.The patient was redirected to his hcp.No patient symptoms/complications were reported.Additional information was received on 12-sep-2020 from an hcp via a company representative who reported that the patient was hearing an audible ala rm from his pump every 15 minutes.The critical alarm was occurring, but the logs had not yet been read.A motor stall was suspected.There were no known environmental, external, or patient factors that may have led or contributed to the issue.The doctor was going to prescribe some oral meds and the patient was instructed to get to the hospital er (emergency room) if needed.The issue was not resolved, and it was indicated that the hcp had no further information to provide regarding the event.The patient status was reported as ¿alive ¿ no injury¿.Additional information was received on (b)(6) 2020 from the patient who reported that his pump failed, and it sent him into morphine withdrawal.He stated that he went into ¿full withdrawal¿ by 11 am saturday and it was terrifying for him and his family and he felt he could have died.He stated that he was twitching and screaming and the er ¿brought me back after hours of infusion to get me back¿ and he went home the same day.The patient stated that he had been through days of horror and he was waiting, and no one had contacted him about a new pump.He stated multiple times that he was very upset and very mad.He stated that he was a veteran who was already 100% disabled and he felt that nobody cared.He stated that he had been having issues over the years that the doctors could not explain.For 2 years he had been going into ¿deep sweats and bed ridden on some mystery thing that no one could figure out¿ and it seemed to be coming from his pump.He stated that he had told his pump doctor and his primary care doctor about all these strange issues, ¿sweats from no place, losing all energy and be down for days¿.The episodes felt like withdrawal to him.The pump doctor told him the amounts matched from pump the fill, so didn¿t believe it was the pump.His primary care doctor ¿ran every blood test looking for why i was feeling this way¿, but no one figured it out.The patient stated that the only variable was the pump because his pump doctor had eventually replaced his catheter with a newer model catheter, but nothing changed, so he knew it was this pump.He stated that ¿it started, the sweats, the bad feelings as soon as that critical alarm went off.Verifying to me this was the issue i have had for years¿.He stated that he had suffered over the years as had his family; he had missed events; and he felt that this pump had made his life a ¿a living hell¿.He did state that he felt the pump was a great tool because it gave you what you needed at a regular interval directly to the spot that needed it and that oral medication was not as good and it hit you in a different way, but the pump had to be working to have the benefit.He felt that he was wasting more time now waiting for his doctor to see him to get a new pump.E also stated that he was a bit scared to have another one.
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Event Description
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Additional information was received from a consumer indicated the patient¿s heart was damaged and after a head ct, because the patient¿s speech had been impaired and the patient could no longer use words that their thoughts wanted them to use, they thought the patient could have had a small stroke.It was noted testing was still going on.
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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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Manufacturer Narrative
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Section d information refers to the main device, the other relevant component includes: product id 8780 lot/serial# (b)(6) implanted: (b)(6) 2017 product type catheter, ubd: 2018-09-30, udi#(b)(4).H6: device code c62968 and evaluation code-conclusion 22 only apply to the catheter.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 manufacturing representative (rep).The patient's pump was replaced on (b)(6) 2020 and when the pocket was opened the doctor noticed there was a small tear in the pump end of the catheter.The doctor revised this section of the catheter.
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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 a consumer on 2020-sep-22.It was reported that since 2014 the patient had complained to their primary care physician and pain management doctor about issues they had been having with their health.It was noted that the catheter was changed out because of the patient's complaints of feeling dizzy and every month getting thrown into what looked and felt like full blown drug withdrawal stuck in their room for 2 days eating and drinking nothing, too weak to do anything.The patient would need to change clothes and sheets every few hours to try and stay warm because of the sweats.By day 3 the patient's wife would get the patient into a car and take them to the emergency room and the patient and their wife thought it had something to do with the pump.The patient came off every drug they ever had with the doctor's approval except for the medications they needed for acid re flulx, cialis, and testosterone shots.The patient could not understand why their body would do this or why the doctors could not find anyissues.The patient had other issues walking and would feel drunk after a few meters.The patient's head did not feel like it should.The patient was trying not to knock their head into the wall from the spasms and twitched like a chicken with its head cut off, with their bones itching from the inside.The patient could not make it stop.It was specified that the pump had stopped on a friday with full withdrawal on saturday.The patient was pumped with the safe amount to get them out of withdrawal but not enough to stop the spasms.On saturday night the patient went on a drug plan until the pump could be replaced.Without any knowledge, the pump rebooted itself on sunday.The patient was on an increased oral medication to manage their pain and withdrawal, but was overdosing themselves on sunday after coming out of severe withdrawal which was why they felt stupid, slurred words, had to walk assisted after sitting down, and felt unlike themselves.This lasted until surgery on (b)(6) 2020, it was noted that the patient, primary care doc, pain doc, and er doc did not have any information that this would happen.While everyone tried to get the surgery going as fast as they could, the patient believed that all concerned may have rushed the surgery to prevent this issue if they had known the pump may come back at any time.The patient had been on the pump for years and thought that because of the withdrawal this was the way they were supposed to feel.It was noted that the patient had to change their lifestyle and stay fit of their pain would come at them like a sledge hammer.The patient did not drink.The patient thought this would be a very bad situation if they were already overweight and had heart issues.It was then noted that the patient did have a heart issue - wolff-parkinson-white syndrome, diagnosed at their last hip replacement.The patient tried to have it fixed but it could not be recreated at the time of the procedure.
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Manufacturer Narrative
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Continuation of d11: product id 8709sc, serial# (b)(6), implanted: (b)(6) 2007, explanted: (b)(6) 2017, product type catheter p roduct id 8780, serial# (b)(6), implanted: (b)(6) 2017, product type catheter product id 8780, serial# (b)(6) , implanted: (b)(6) 2017, product type catheter.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 consumer reported that while the patient was in the er prior to replacement on (b)(6) 2020 that the patient's pump stopped and then restarted 3 days later.When it stopped the patient went into withdrawals and was placed on oral morphine and then when it restarted they had an overdose.The patient was requested to follow-up with the physician regarding device location.
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Manufacturer Narrative
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Continuation of d11: product id: 8780, serial# (b)(6), implanted: (b)(6) 2017, product type: catheter.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 pump and catheter were returned for analysis.No rotor study and no dye study were performed.It was reported that the patient had experienced a ¿sudden loss of therapy¿ and ¿recovered without sequela.¿.
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Manufacturer Narrative
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Continuation of d11: product id 8709sc lot# serial# (b)(6) implanted: 2007-(b)(6) explanted: 2017-(b)(6) product type catheter p roduct id 8780 lot# serial# (b)(6) implanted: 2017-02-15 explanted: product type catheter product id 8780 lot# serial# (b)(6) implanted: 2017-(b)(6)explanted: product type catheter 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 consumer via a user facility reported the patient's alarm went off on the pump at 5pm on friday and after three hours of hunting for someone the patient was told the pump had a critical error and had stopped.The patient was given meds to prevent withdrawal but they did not work.The patient went into complete morphine withdrawal and it took hours to stop the yelling, twitching, and spasms.The patient was seen in the emergency room and the doctor got the patient out of withdrawal as good as they could with oral drugs.The patient took the drugs until the pump could be replaced.During the oral meds the patient had problems standing, speaking, doing anything normal.7-8 days later the surgery was scheduled and during interrogation it was noted the pump had restarted on its own.It was noted this occurred the day after the patient had been taken off of withdrawal, so there pump reactivating could have caused an overdose and killed the patient.The patient went from complete withdrawal to overdosing 200% morphine per day from sunday to the next monday.The patient was feeling bad during this time.
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Manufacturer Narrative
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Analysis of the implantable infusion pump (s/n (b)(6)) found a stall due to wear and/or corrosion and/or lubrication and a stall due to shaft bearing.Analysis of the implantable intrathecal catheter (s/n (b)(6)) found damage to the transition tube.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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Search Alerts/Recalls
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