MEDTRONIC NEUROMODULATION IMPLANTABLE DRUG INFUSION PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number NEU_UNKNOWN_PUMP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Insufficient Information (4580)
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Event Date 01/07/2021 |
Event Type
Injury
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Event Description
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Information was received from a consumer via a user facility regarding a patient receiving dilaudid, fentanyl, clonidine, baclofen, and ketamine via an implanted pump.It was reported the patient thought they had severe narcolepsy for the last 2 decades and it wasn't until after spending a year being detoxed off the opiates that they realized that's not the case at all.The patient had just been over medicated and it was suppressing their breathing.In addition, the patient developed severe levoscoliosis at the age of 40 with no previous spinal issues.It was noted this was a critical life threatening failure.The patient mentioned that they saw a new team of physicians during covid and they convinced the patient they were not narcoleptic and agreed to help the patient get off the drugs.The patient was in a narcotic drug haze for 20 years.
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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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