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 the consumer (con) regarding a patient who was receiving morphine (dosage/concentration was not available) via an implantable pump.The indication for use was non-malignant pain.It was reported that the patient had a stim system taken out last year , the patient reported no issues with stim system.The patient reported epidurals and then got pain pump implanted on the right side and four months later the suture opened and had five holes in gut and was risk of sepsis, so they removed the pump on (b)(6) 2021.The patient reported he healed and eventually put another pump on the left side which was current pump.The patient stated nothing was wrong with the pump at the time and that he overdid it and was his fault as to why the incision was opening.The patient also mentioned he has had eight broken ribs from accident and has five titanium ribs and is in pain all the time.The patient mentioned the pump helps but still has pain.
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