MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Insufficient Information (4580)
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Event Date 04/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient receiving clonidine, bupivacaine, and dilaudid via an implanted infusion pump.The indication for use was spinal pain.It was reported about 4 days ago when the patient was used a bolus, they became extremely overwhelmed like if the patient were to "go to the er and get an iv dose of dilaudid".It was noted the bolus also lowered their blood pressure.The issue began after a bolus, but now the patient constantly felt like they were getting too much and stated "it takes my breath away" and "if i close my eyes i could fall asleep".The patient called their doctor but they were advised to wait until next appointment in may to be seen but patient can't wait that long stating they are "sitting with a thing of narcan waiting to od any time".The patient was redirected to their hcp.
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Event Description
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Additional information was received from the healthcare provider indicated that the issues were due oral medication.Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.
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Manufacturer Narrative
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Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report had malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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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