Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-sep-2017, 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) and a company representative regarding a patient receiving morphine via an implanted pump.The indication for pump use was non-malignant pain.It was reported that during a back surgery neurosurgery reported that the catheter was cut during micro discectomy.The patient status was reported as ¿alive ¿ with injury¿ with the details of the injury noted as ¿csf (cerebrospinal fluid) leak¿.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that the catheter was not visible on x-ray.A portion of the catheter was removed during the procedure, and it was noted that the catheter would have to be replaced at a later time.The pain physician was turning the pump down to minimum rate as the pump was no longer connected to a catheter.The issue was not resolved at the time of the report.
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