Concomitant medical products: product id: 8840, serial# (b)(4), product type: programmer, physician.Product id: 8870aar01, serial# (b)(4), product type: software.Information references the main component of the system.Other relevant device(s) are: product id: 8840, serial/lot #: (b)(4), ubd: , udi#: (b)(4); product id: 8870aar01, serial/lot #: (b)(4), ubd: , 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 professional via a company representative regarding a patient receiving baclofen (600 mcg/ml at 73.53 mcg/day) and morphine (8 mg/ml at 0.9803 mg/day) via an implanted pump.The indication for pump use was non-malignant pain and post lumbar laminectomy syndrome.It was reported that when the patient came in for a refill on (b)(6) 2018, the pump was interrogated and it showed the low and empty reservoir alarms occurred, however, there was still 4.6 ml left with 15.6 ml dispensed.The logs from the refill on (b)(6) 2018 were reviewed and showed that the pump was changed at 16:27 and then changed again at 16:29 after which the empty and low reservoir alarms logged.No logs were printed which captured the change made.It was noted that the 8840 clinician programmer they were using had an (b)(6) software card which was not the current software card version.They were not sure if this was the 8840 clinician programmer used for the last refill on (b)(6) 2018 as well or if they had been using this 8840 clinician programmer for other patient¿s too since they were a large account with many 8840 clinician programmers.No patient symptoms were reported.There were no complications.
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