Concomitant medical products: product id: 8598a, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Product id: 8596sc, serial# (b)(4), implanted:(b)(6) 2017, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: (b)(6) 2019, 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 consumer regarding a patient who was receiving bupivacaine, dilaudid, and another unknown medication via an implantable pump for malignant pain.The drug concentration and dose rates of the pump medications were unknown.It was reported that the patient was having her pump replaced on (b)(6) 2018 due to normal battery depletion.It was noted that it had almost been 5 years and the pump has a shelf life.It was further reported that a physician had laid the catheter on her sacroiliac (si) joint which had been giving her terrible sciatic nerve pain caused by the pump itself.It was further noted that the catheter was shattered so they had to implant a new catheter.It was indicated as having been unknown if the change in therapy/symptoms were sudden or gradual.The date of the event regarding the shattered catheter was unknown.The terrible sciatic nerve pain had occurred in (b)(6) 2018 (month and year known only).It was noted that the patient sees two physicians.No further patient complications have been reported as a result of this event.
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