Concomitant medical products: product id: 8780, serial# (b)(4), implanted: 2021, explanted: 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 31-aug-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving morphine (5 mg/ml at 1 mg/day) via an implantable pump for unknown indications for use.It was reported that the patient's pump was flipping and the patient has intermittent return of pain.The exact date was unknown; however, the patient noted approximately 3 weeks ago.The cause of the event was undetermined.The pump pocket was revised on (b)(6) 2022.It was noted intraoperatively that the catheter on the side of pump was twisted.A 8784 was attached to existing 8780 and pump side of catheter was replaced.The catheter successfully aspirated, pump secured, and surgery successful.This issue was resolve at the time of report.The patient's weight and medical history was asked and will not be made available.The patient's status at the timeof report was alive - no injury.
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