Concomitant products: product id: 8782, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 05-sep-2020, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 10-dec-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (2000 mcg/ml at 1289 mcg/day) via an implanted pump.The patient¿s medical history was noted to be motor vehicle accident and quadriplegic.The indication for pump use was intractable spasticity.It was reported that the patient¿s therapy efficacy was lacking, and the patient was becoming more rigid despite a large daily dose with flex dosing.A ct dye study was performed, and they were unable to aspirate from the catheter.It was noted that the hcp was very unhappy with the lack of fluoroscopy discovery with the catheter and it was extremely hard to view under x-ray.It was unknown if there were any environmental, external, or patient factors that may have led or contributed to the issue.The catheter was replaced.The pump dose was decreased to 800 mcg/day.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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