MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-40 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Memory Loss/Impairment (1958); Pain (1994); Confusion/ Disorientation (2553); Insufficient Information (4580)
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Event Date 07/11/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_prog, serial# unknown, product type: programmer, physician.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 multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving fentanyl (2000 mcg at 1326.20218 mcg/day), morphine (9.5 mg at 6.29946 mg/day), and bupivacaine (18.9 mg at 12.53261 mg/day) via an implantable pump for unknown indications for use.It was reported that on (b)(6) 2021 the hospital called and the patient was admitted due to increased pain secondary to ptm device not working. the patient was administered 50mcg/hour fentanyl patch and intravenous (iv) fentanyl with pca doses. on (b)(6) 2021 the patient reported the pump has not been working. exam showed the last bolus was given on (b)(6) 2021 and that the ptm was not working. examination also indicated the patient was confused and difficulty with memory likely withdrawal symptoms/secondary to withdrawal symptoms. the patient was provided with a new ptm and administered a bolus in clinic on (b)(6) 2021. on (b)(6) 2021 the living facility reported pain had uncontrolled pain secondary to pump not working. the outcome of the event resolved without sequelae on (b)(6) 2021. the device diagnosis was other ptm no longer working and the clinical diagnosis was intrathecal (it) medication withdrawal. the event required in patient hospitalization. the etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. the event was related to programming/refill. the event date was (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 professional (hcp) via a clinical study reported on 2021 (b)(6) the patient reported the patient's living facility called to report the patient was in pain and inconsolable secondary to pump not working.On 2021 (b)(6) the patient denied withdrawal symptoms.The model number of the ptm was unknown, the serial number was not collected, and the status of the ptm was unknown.
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