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It was reported that the area of the pump implant was swollen and sensitive.The patient stated that she could not wear jeans because of pressure and it was sensitive in the area of the pump.The patient also stated that when she would sit down and bend over she would have to spread her legs to bend over because the pump was right there and it would put pressure on the pump area and it hurt.This had been happening since pump implant.The pump was implanted in the front of the patient¿s stomach, on the right side, not very far from rib because the patient was small and did not have enough fat in her back.The patient¿s healthcare provider (hcp) told her that the incision was still healing.The patient stated that her hcp started her medication at a low dose and increased 10% each visit up to 4 because of the side effects of the medication such as headaches and vomiting.The patient stated that the week prior to the report she ¿had a bug¿ and was vomiting.The patient noted that she would get headaches from her sinus.The patient did not want the side effects from the medication.The patient had an appointment scheduled for (b)(6) 2014 to see the hcp.The device system delivered prialt.It was later reported by the hcp that there was minimal post-operative swelling which required no treatment.There were no signs or symptoms of infection.The patient was without side effects and was making progress.It was later reported that the hcp was unable to confirm the adverse event.The hcp stated that the patient had adequate pain control with improved activities.It was reported that patient had return of symptoms.Patient was implanted on (b)(6) 2014; 2 weeks later she had a refill and every week since she had gone in for a refill and increase in dose.This week they upped her to 3.7; she¿d been told to wait 48 hours for it to "hit" by her hcp.Patient usually slept during that time and when awake felt good for "a short time"; however 1.5-2 days post this she goes back to feeling bad again.Patient had fibromyalgia and had it for a long time and she used to be hyper and ride dirt bikes etc.But now "can't get nothing done, lays on couch, drags feet to bathroom because they hurt from fibromyalgia¿.Patient had a chiropractor/nurse that would give her shots in the back to loosen up fibromyalgia, but her pump managing hcp said no more shots.Hcp told her they put pump in her stomach because she was too small to put in her back.Patient was (b)(6) lbs and said there was not enough fat on back.Patient¿s stomach was lopsided and ¿looked all chopped up with all the scars over her body¿.Patient¿s next refill was 2 weeks and she ¿doesn't think she can last that long¿.Patient¿s insurance paid for this but it's not working she was on the couch, stays in pajamas, cry all the time, can't move, it's sad.Reporter indicated never having therapeutic effect.Patient had increased baseline pain, bones, from the neck down; difficulty walking.Patient cries a lot and their body jerks.The pump was for arthritis pain and fibromyalgia and patient takes oral meds for this.Patient knew the difference between the fibromyalgia pain and the arthritis "bone" pain, from the neck down and indicated "i can deal with the fibromyalgia." at the last refill on (b)(6) 2014 prialt was increased to "4.0." patient had another hcp appointment on (b)(6) 2014.With regards to drug in the pump, it was stated that patient was not having any help from it.The pain hadn't changed at all and they would upped it to 4, but i'm just as bad as i was" before the implant.Patient indicates "she knows all about that prialt side-effects.I can hardly get around by myself.My husband is my caregiver because i can't function.The drug has been increased every 2 weeks, but this time it's waiting 3 weeks, "it's been awful¿.Patient had difficulty walking and spouse took them to the hcp in a wheelchair."each time they're upping it but it's not helping me." the last 3 increases "have not worked" not even for the 1st night.Patient was allergic to zephyr and prozac.Patient had been on every pain medication that's possible, even the patch, hydrocodone, oxycodone, oxycontin and had the spinal thing done which didn't do anything¿.It was stated that the trial helped for a day or two, it worked, but once he put this in, he said it can take 48 hrs when he ups it.That first night patient could sleep, otherwise ¿i can't move when i wake up.Maybe it will work overnight.Or, if it's not raining, maybe it will work for a day.But the rain and the cold make the pain worse¿.Patient was told they can no longer have "muscle shots" in their back.Hcp had told the patient that they were going to increase it slowly," to try and prevent side effects while they patient to where she needs to be.Patient can tell the difference between the fibro pain and the bone pain of arthritis."from my neck all thru my body.It's hard to live with".Patient was on 2 meds for the arthritis, plus the pump and it's not working."i can't eat, i can't sleep, i can't walk, and gets dizzy." "it's hard to wear clothes because of the fibromyalgia, they smother me.I've had my heart checked.My brain is good." "i can't take care of myself." patient drinks mainly water now."the only thing i can take with it is tylenol, but my other dr says don't take it, it's too hard on the stomach." patient had to retire early "because i can't do my job.Now i'm on disability." ¿i cry so much, my body jerks.I hurt in areas that i shouldn¿t hurt in and my nerves are getting so bad because i hurt so bad¿."they cut me on the side for the catheter, cut my back to run it up and patient does not feel it "dripping, especially when you're in so much pain." patient was allergic to couple of meds but had not had any side effects from the prialt.Patient does not like the "fuzzy" in their head from narcotic meds.Patient¿s spouse commented "you haven't been this bad since you stopped taking the patches." per pump telemetry logs daily dose had a 7% increase; infusion dose increase 7%; prialt 3.999 mcg/day; 25.0 mcg/ml; refill 44 days.It was reported that the patient had not felt ¿right¿ since her implant.At each refill, her dose was increased, but did not seem to treat her symptoms.The patient felt nauseous, dizzy, and had pain from her head to her toes.It was also noted that the rain frequently affected her pain.She used to be ¿hyper¿, but could barely get up and move around without breaking a sweat since the pump was implanted.In addition, since about a week and a half prior to report, the patient¿s left leg was going numb after short periods of activity.It was stated that she might have two good days out of a month.The patient had stopped taking hydrocodone when her pump was implanted, but the healthcare provider (hcp) reinstated it two weeks at a time because her therapy was not treating her pain as desired.Additionally, the patient had fallen in the shower three months prior to report, though it was not indicated that there was a relation to the implanted device or therapy.Prior to the pump implant, the patient also had the following issues: fibromyalgia, anxiety, pain, nausea, dizziness, and weakness that required her to sit in the shower.It was noted that the healthcare provider was unsure what caused the weakness.Information was received from a consumer regarding a patient receiving intrathecal hydromorphone (unknown concentration) 3.18 mg/day via an implanted pump.The pump's indication for use (ifu) was listed as non-malignant pain and failed back surgery syndrome.Concomitant medication was gabapentin, ambien and b12 shot.The patient was on lyrica previously and had ¿ambreo¿ but was not currently using either.Initially the pump had helped with the patient¿s pain however the pain control was now unsatisfactory.At the last appointment on (b)(6) 2015 the nurse asked about her pain level and the patient said it was between 8-10.The nurse had increased the dosage 10 percent two months ago and the patient could not feel a difference however instead of increasing the dosage, the nurse decreased it.The nurse didn't flush the pump, just withdrew old medication and put in new medication.The healthcare provider disagreed with patient's pain experience and said that it was nonsense.Since receiving the implant the patient had gained about 45 pounds and questioned if that was a side effect of the medication.The patient experienced side effects noted as very tired, no energy, doesn't want to be around anybody, has to sit down two or three times because she breaks into sweat when cleaning.The patient was on 1800mg of gabapentin and her sweating got worse.They thought it was causing the issues so lowered her to 800mg but she was still sweating.If she bends over the pump hits her tailbone.The patient had arthritis and fibromyalgia but she had them before the pump.The patient felt like she was burning up.The patient had shots in their neck for fibromyalgia.The first medication used in the pump did not work (unknown medication).The urine results (from 2 weeks ago and 2 months ago) found fentanyl however the patient did not take fentanyl.The patient¿s husband used fentanyl patches and she usually places them for him.The patient planned to follow up with her primary care physician on (b)(6) 2015.(omitted information related to (b)(4)- car accident / bruising).Additional information was receive from the consumer indicated that the pump had been giving her issues since implant.It was reported that the pump had shifted/moved and for the past month the patient had been experiencing withdrawal.It was noted that initially the patient was bed ridden from withdrawal symptoms; she was getting better but still had weakness and anxiety.The healthcare provider turned down the pump medication and surgical removal was anticipated.No further complications have been reported.
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Concomitant medical products: product id 8780 lot# serial# (b)(6), implanted: (b)(6) 2014, explanted: (b)(6) 2020 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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