|
Correction - h1: with removal of c35016, the event is now reportable for malfunction instead of si.B2, outcome attributed "other" no longer applies, selected incorrectly.H6, c35016 no longer applies.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.
|
|
Additional information was received from the hcp on 2018-jul-23.There is presence of intrathecal pump failed back syndrome, lumbosacral.Patient allergies include pcn [bicillin c-r,] hives, butazolidin [phenyl], adhesive tape (blisters).She is ¿well-known to the pain center chronic low back pain from postlaminectomy syndrome and chronic arachnoiditis.She had an intrathecal pump placed years ago that delivers morphine, baclofen and bupivacaine.She recently had her pump replaced 1 month ago due to battery end of life.The patient is here today ((b)(6) 2018) for postop evaluation.The patient complains of pain at the pump insertion site-tenderness and occasional pains.She states she felt it was ¿sticking under her ribs.¿ her back pain seems to be well controlled.¿ the patient was alert and oriented.There was slight seroma at insertion site.Sterile aspiration of pump site right upper quadrant of any fluid possible seroma.The wound was clean and dry, no erythema, and the pump is slightly tipped forward.The patient was ¿doing well, no complications.¿ the patient presented in a wheelchair for intrathecal pain pump battery replacement follow up.She reports acute abdominal pain in the area where her incision is, and signs of ecchymosis as well as swelling.It was noted in the right upper quadrant of the abdomen close to her ribs, pump site has ecchymosis and some bulging over the pump site with slight tenderness with palpation no apparent signs of infection.The pain is sharp and is worse with movement and straining to use the bathroom.This pain started a week ago (prior to visit date of (b)(6) 2018), she states "it feels like the pump is trying to come out.¿ she is concerned about the location of the pump.The appointment on (b)(6) 2018 indicated that the patient was to continue medications as prescribed.They discussed with patient that his medication doses currently exceed the recommended dosages.He verbalizes understanding.Discussed with patient the risks of opioid medications including but not limited to dependence, addiction, respiratory depression, and death.Patient was advised not to consume etoh or operating heavy machinery or vehicles while taking this medication.Patient verbalized understanding.The patient would return to clinic on (b)(6) 2018 for pump refill.The patient presented in a wheelchair on 4 l o2 for follow up intrathecal pump battery replacement.Since the procedure she has been complaining of increased back pain and abdominal pain near the battery site.She states "i think it is too high up and tubing is near my groin.¿ she is unsure the pain pump is working.The o2 sat was at 83% upon assessment, found the o2 was not flowing due to a kink.Straightened the kink and o2 went up to 89%.Reminded patient of taking deep breaths.O2 fell again to 83%, increased o2 to 5l and to 91 %.The doctor was notified and will continue to monitor.Current outpatient prescriptions consist of furosemide 20 mg oral tab, warfarin sodium 5 mg oral tab, gabapentin 100 mg oral cap, nystatin 100000 unit /gm external cream, hydrocodone-acetaminophen 5-325 mg oral tab, oxybutynin chloride 5 mg oral tab, acetaminophen 500 mg oral tab, amlodipine besylate 2.5 mg oral tab, diphenhydramine hci 25 mg oral cap, clotrimazole-betamethasone 1-0.05 % external cream, ammonium lactate 12 % external lotion, bisacodyl 10 mg rectal suppos, fleet enema 7-19 gm/118ml rectal enema, peg 3350 oral powd pack, carbamide peroxide 6.5 % otic solution, vitamin c 500 mg oral tab, senna-docusate sodium 8.6-50 mg oral tab, albuterol sulfate hfa (proair hfa) 108 (90 base) mcg/ act, inhalation aero soln, levothyroxine (synthroid, levothroid) 137 mcg oral tab, atorvastatin (lipitor) 10 mg oral tab, loratadine (claritin) 10 mg oral tab, omeprazole 40 mg oral capsule delayed response, ergocalciferol (drisdol) 50000 units oral cap, multiple vitamins-minerals (multivitamin with minerals) oral tab.Unrelated patient medical history and surgical history was listed.There were no further complications reported/anticipated.
|
