Concomitant medical products: product id 8781 lot# serial# (b)(4), implanted: (b)(6) 2021, 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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Information was received from a healthcare provider (hcp) regarding a patient who was receiving bupivacaine (20 mg/ml at 6 mg/day) and fentanyl (2000 mcg/ml at 600 mcg/day) via an implantable pump for unknown indications for use.It was reported that during refill on (b)(6) 2022, they expected 23 ml and got back ~39 ml.The hcp stated it was a different hcp that did the refill but they reported the initial 18 ml or so was clear then it started coming out looking like it had a significant amount of blood in it.They aspirated the reservoir a few times until it was clear again but were wondering how it could have turned color and where it might have been coming from.The hcp stated that the patient's pain was "out of control" so they were planning to add an additional medication to the mix which is why the refill was being done.The hcp does not think the needle came out of the pump septum and did not think there was any significant swelling or anything at the pump pocket site to indicate an issue with the pocket.The hcp doing the refill did notice some swelling near the catheter site, but not the pump pocket.Of note, the patient had a previous refill on (b)(6) 2022 where there was no volume discrepancy.The hcp stated that the patient was having a contrast study done and was able to confirm the study was normal.
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