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
Low Oxygen Saturation (2477); Cognitive Changes (2551); Confusion/ Disorientation (2553); Lethargy (2560); Insufficient Information (4580)
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Event Date 12/05/2021 |
Event Type
Injury
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Event Description
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Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving hydromorphone, fentanyl, and bupivacaine via an implantable pump.It was reported, on (b)(6) 2021, the patient's spouse noted the patient became more sedated and less arousable over the past few days.The clinical diagnosis was altered mental status.The patient arrived via ems, neither awake nor oriented with o2 saturation of 72%.The patient was given oxygen and narcan and reportedly responded to the narcan.The patient was placed on 2l oxygen and iv narcan with minimal response.Patient transferred to hospital for further evaluation and treatment.Pump set to minimum flow.It was indicated the event was related to the device or therapy and related to the increased dose of hydromorphone and fentanyl.The event resulted in a life-threatening illness or injury and required in-patient or prolonged hospitalization.The event was ongoing.
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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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Additional information received from a healthcare provider via a clinical study reported the patient had been admitted to the icu with altered mental status on (b)(6) 2021.On (b)(6) 2021, the patient's condition had improved and the issue was resolved without sequelae.The patient was scheduled with the soonest available office visit on (b)(6) 2021.
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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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Event Description
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Additional information received from a healthcare provider via a clinical study reported the patient was hospitalized on (b)(6) 2021 due to opioid overdose.The hcp prescribed oral oxycodone 5 mg and discontinued it fentanyl and hydromorphone.The issue resolved without sequelae on (b)(6) 2021.
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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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