Information was received from a healthcare provider via a clinical study regarding a patient receiving dilaudid (4.0 mg/ml at 3.1548 mg/day), bupivacaine (30.0 mg/ml at 23.661 mg/day), compounded baclofen (200.0 mcg/ml at 157.74 mcg/day), and clonidine (200.0 mcg/ml at 157.74 mcg/day) via an implanted pump.The indication for use was spinal pain.It was reported the patient had shortness of breath and increased pain on (b)(6) 2018.The clinical diagnosis was it medication side effects.The patient presented to the emergency department with lower extremity numbness on (b)(6) 2018.The next day therapy was suspended via magnet while in the hospital at 00:10.Later that afternoon, the patient reported burning pain had improved.The healthcare provider attributed this to either hyperalgesia or over-medication of bupivacaine.Therapy was resumed and daily rate was decreased 50%.On (b)(6) 2018, the patient had upper extremity numbness.The patient was examined, on (b)(6) 2018, and revealed increased radicular numbness.The patient's it rate was decreased by 33% and discussed catheter revision.The next day the patient had increased tingling following ptm activations.On (b)(6) 2018, the patient had uncontrolled pain secondary to it rate decreases due to side effects.The it rate was decreased again and started extended release morphine.On (b)(6) 2018, the pain had improved and side effects had resolved.The patient declined catheter revision.It was indicated the event was related to the device or therapy and related to the drugs hydromorphone, bupivacaine, clonidine, and baclofen.The event resulted in in-patient hospitalization.The issue resolved without sequelae on (b)(6) 2018.Additional information reported the hospitalization was a result of the reported event.The ca use of the burning pain was unknown.The patient's baseline weight was (b)(6).
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