Information was received from a consumer regarding a patient receiving baclofen, clonidine, sufenta, fentanyl and ¿bivercane¿ via an implanted pump.The indication for pump use was non-malignant pain.The patient reported that in (b)(6) 2021 she began to have a lesion open up right on top of the catheter in her back.She had been treated by wound care ever since, but she was to have the pump removed tomorrow.
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Concomitant products: product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2007, product type: catheter, product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter.Product id: 8596sc, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 17-jul-2009, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 25-mar-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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