Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 15-mar-2018, 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 gablofen (2000 mcg/ml at 1018 mcg/day) via an implantable infusion pump for intractable spasticity.It was reported that the patient allegedly had a reaction to an antibiotic, resulting in sepsis and patient needing to have the pump and catheter explanted.The issue was resolved at the time of report.The patient's weight and medical history were asked but unknown.The patient's status at the time of report was alive.No injury.
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