MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of consciousness (2418); Lethargy (2560); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/21/2022 |
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 healthcare provider regarding a patient who was receiving marcaine (bupivacaine) (9 mg/ml at 3.25 mg/day), fentanyl (1500 mcg/ml at 399.45 mcg/day), and dilaudid (hydromorphone) (4 mg/ml at 1.0652 mg/day) via an implantable pump for non-malignant pain and failed back surgery syndrome.It was reported that the patient had a pump refill yesterday ((b)(6) 2022) and on the date of this report, the patient was admitted due to lethargy and being unresponsive at home.It was noted they had given the patient narcan and now they were wanting to have the pump checked and turned off.The hcp confirmed the pump was not alarming.
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Search Alerts/Recalls
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