MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
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Model Number 8637-20 |
Device Problems
Obstruction of Flow (2423); Infusion or Flow Problem (2964); Patient Device Interaction Problem (4001)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994)
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Event Date 12/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 13-jul-2021, udi#: (b)(4).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 (hcp) and a consumer via a company representative regarding a patient receiving fentanyl (500 mcg/ml at 24.03mcg/day), bupivacaine (20 mg/ml at.961 mg/day), and clonidine (300 mcg/ml at 14.42 mcg/day) via an implanted pump.It was reported that the patient was having inadequate pain control.The patient stated that he felt that the pump was at times "ineffective¿.This prompted the hcp to do a dye study during which he was unsuccessful in aspirating from the catheter.The pump logs were also reviewed.The plan was then for the patient to be taken to surgery to open the pocket and ascertain what needed to be done to revise or correct the issue.The patient was taken to surgery.The pocket was opened, and the hcp attempted to aspirate from the cap (catheter access port) and at first, he was unsuccessful.Ultimately, he disconnected the catheter from the pump and found some biological debris (unknown tissue) surrounding the pump connector.He removed the debris; the catheter flowed freely; and he was then able to aspirate from the catheter.He aspirated 2 cc of drug from the catheter and proceeded with injecting contrast dye and followed it to the intrathecal space in the spine.The incision was then closed, and the pump was primed appropriately in the recovery area.There were no environmental, external, or patient factors that may have led or contributed to the issue.The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
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