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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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| Model Number 8637-40 |
| Device Problems
Obstruction of Flow (2423); Device Ingredient or Reagent Problem (2910); Infusion or Flow Problem (2964); Insufficient Information (3190)
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| Patient Problems
Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Nausea (1970); Overdose (1988); Pain (1994); Scar Tissue (2060); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Chills (2191); Therapeutic Response, Decreased (2271); Anxiety (2328); Complaint, Ill-Defined (2331); Malaise (2359); Shaking/Tremors (2515); Cognitive Changes (2551); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 06/14/2013 |
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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 foreign consumer via a manufacturer's representative regarding a patient who was receiving morphine (unknown concentration and dose) via an implantable pump for non-malignant pain.It was reported the patient stated their pump never worked as well as their first pump and they took a while to recover from the implant.The patient stated they had withdrawal symptoms, but not regularly.They stated this time their withdrawals were more severe and their pump was faulty.The patient had been to see their general physician and their symptoms included sense of smell and taste changes, becoming shaky and needing to sit down, vomiting, nausea, symptoms similar to convulsions, and getting cold which lasts for 12 hours, then goes back to normal.It was stated this lasted over 3 days the last time.It was indicated no troubleshooting or actions had been taken yet.Contributing factors were unknown.The issue was not resolved.Additionally, the title of the report was "query overdose symptoms" [clarification has been requested].
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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.It was indicated the patient did report overdose symptoms.It was unknown if troubleshooting had been performed.The representative suggested the patient make an appointment to see their refilling physician, but it was unknown if they had been to see them.
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Event Description
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Additional information was received in response to a request for follow-up during a review with the patient and physician.It was related that the patient complained of withdrawal symptoms when "very busy" doing manual labor involving heavy lifting, bending and stretching for prolonged periods of time.The symptoms could last for up to a day following this type of activity.The symptoms were occurring every month or so, but the patient had not kept a record of dates or times.The manufacturer representative interrogated the pump and there had been no incidents of motor stall or other events since (b)(6) 2019 (as far as the logs go back).It was also confirmed that the patient's pump was not part of a recall.It was indicated that based on that the patient was on hydromorphone the physician concluded that it was possible that the patient may experience quickly onset of withdrawal symptoms if the catheter was being "kinked" when bending/twisting.The physician reportedly could not rule out a granuloma.It was noted the patient recalled that the catheter was supposed to be replaced by another physician when the latest pump was replaced, but that didn't happen for an unknown reason.A possible dye study was discussed, but the patient stated this had been done at the pump replacement.The patient's new physician was going to discuss catheter replacement (adding a new catheter alongside the old existing one) with the original implanting physician that week.The physician had prescribed some oral opiates to manager their withdrawals in the meantime.It was noted that the physician felt that if the new catheter didn't resolve the issue, there was nothing more to do as it was not pump/catheter related and the patient would need to continue to manager their symptoms using oral medications.
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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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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.It was indicated the catheter was too scarred-in, so it was impossible to remove in its entirety.It was removed in pieces, and as much as could be dissected out.The patient's pump remained implanted and in use.It was indicated since the replacement the patient was doing "ok.".
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Event Description
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Additional information was later received.It was reported that a catheter dye study was done on (b)(6) 2020, but the results were nad [presumably no abnormality detected].However, the patient was adamant that there was something wrong with the pump and/or catheter.The patient had been seen by the physician who had implanted the pump, and the patient had now asked another physician for a catheter replacement which was due to take place on (b)(6) 2021.Further information received from the patient stated that the patient had been very sick in pain and was very tired.The patient stated they had been praying to please not let them wake up, and that if they died and went to hell they probably would not notice.The patient had been "knocking [their self] out with medication but the pain is so high even that is hard." the patient had asked for a medication review and to change from hydromorphone to morphine sulphate before the operation as taking oral hydromorphone was making the patient quite ill and their concern was that having the same medication in the pump would not help.The patient noted that they had morphine sulphate in their first pump successfully.The patient now had morphine sulphate (ordine) now and did not have the bad feelings they had with hydromorphone.The patient stated that their doctor did not make them an appointment or write a script to fill the pump with morphine sulphate despite the patient asking.The patient also noted that they explained they wanted their pump read before the operation as their wife woke up saying the patient's pump made a lot of noise/"crunching sound" and it sounded like beeping.The patient did not hear it but they used to hear it make "pressure sound." the patient was worried the pump was broken.The patient's pain was so high and the pump was doing nothing (per the patient).The patient was also scared that after the catheter was replaced, it would still not work due to the pump.The patient noted that they thought if the catheter was blocked the built up pressure would cause a lot of strain on the pump.The patient noted again that they were promised that when their current pump was put in, both the pump and catheter would be replaced but instead they did not replace the catheter.The patient said they were very sick and asked their general practitioner to organize a dnr.The patient stated they scream and cry in pain every day.The patient wanted to start with a new doctor that would listen and help him.
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Manufacturer Narrative
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Continuation of d10: product id: 8709, serial# (b)(6), implanted: (b)(6) 2004, product type: catheter.Section d information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(6), ubd: 2006-02-05, udi#: (b)(4).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 2021-feb-24.It was reported that the patient saw a ¿cloud of black residue¿ in the syringe that came out of their catheter during a backflush.It was again stated that an hcp thought it was the catheter around 2013/14 and booked a replacement, but another hcp stopped him.The patient stated that they were ¿waiting to live again.¿ it was also noted again that the pump made loud noises at night that work up the patient¿s wife.It was reported this occurred in december, but it was also stated that the patient had told specialists for years before now that the pump makes a ¿hissing sound so loud others can hear it.¿ this was also described as a ¿pressure like hissing sound,¿ and it was noted the sound had stopped since the patient¿s pain increased and their withdrawals became really serious in november.The patient indicated they thought the sound was due to a blocked system and when the pressure got really high, something had to give and it ¿squirts out somewhere.¿ the patient repeated the hissing had stopped now after the squirting sound and the patient would have some improvement sometimes a few days, but it had been months now.The patient stated they could not live without a pump and that their pain was unbearable.The patient also noted that an hcp told the patient not to have the operation in december in case there were complications, and that the hcp told the patient that it could be in early january.However, then the patient was told that the [operation] was not going to happen for well over 2 months.The patient stated that they thought their body would ¿give in,¿ and also that they had chest pain and pain in their arms, sometimes struggled to breathe.The patient noted that there are times that they go down screaming in pain.The patient reported they had done nothing but suffering since 2013 when they switched from the ¿gas pump¿ to the ¿new roller pump style pump.¿ additional information was received from a manufacturer representative on 2021-mar-05.The manufacturer representative who was present for the catheter replacement case on 2021-mar-05 reported that there were attempts made to remove the old catheter, but this could not be removed in full.The parts that were removed were kept at the hospital for pick-up to return for analysis.
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Manufacturer Narrative
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Continuation of d10: product id 8709 lot# serial# (b)(6), implanted: (b)(6) 2004, explanted: (b)(6)2021, 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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Manufacturer Narrative
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Continuation of d10: product id: 8709; lot#serial#: (b)(6); implanted: on (b)(6) 2004; explanted: on (b)(6) 2021; product type: catheter; h3: the catheter was received in three segments, comprising of the proximal segment with the sc (sutureless connector), the pin connector, and part of the distal segment.The returned catheter segments were device was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing.The catheter was returned and no anomalies were noted on microscopic inspection, the catheter was patent, and passed pressure leak testing.H6: annex b code b01 and annex c code c19 pertain to the catheter (concomitant product).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.
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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 foreign consumer via a company representative.The patient suffered from acute chronic pain in their neck and had so since 1987.The patient received their first intrathecal morphine pump in 2003 and for 10 years life was good.In 2013 their pump needed replacing, but things went wrong and instead of fixing the problem the patient was exposed to surgery after surgery trying different stimulators; around a dozen operations.The patient was promised that if this stimulator did not work, they would replace the pump.This happened 3 times.It was further noted that again the surgeon insisted on trying a new stimulator first, but this did not work.The patient was then promised a new pump and a new catheter.It was further reported that in 2013 the patient¿s specialist at the time suspected it was the catheter, but the head of the department stopped him from changing it.The patient only received a new pump and still had the 2003 catheter after the operation.It worked for a while and the patient started exercising and feeling better, but the pain returned.They did a fluoroscopy and while evacuating the catheter it had filled with black residue.They hoped this would fix the problem by unblocking the catheter.It did work again for a while but soon the patient was having to keep returning to have it turned up.Another fluoroscopy was performed, and this time they could not access the catheter but the needle was in the port.It was noted that a company representative was considering that it must be blocked.I have had a few now watching the dye flow up the catheter but the patient saw nothing on the screen.All of a sudden the patient was told everything was working and ok.But yet the patient received no pain relieve.They finally decided to replace the catheter in (b)(6) of 2021.A 5 hour operation was noted and the patient remembered waking up convulsing on the bed while it was being done.It was noted that the patient had signed the release form which said catheter replaced x 2.
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