Concomitant medical products: product id: 8780, serial #: (b)(4), implanted: (b)(6) 2016, product type: catheter.
Product id: 8780, serial #: (b)(4), implanted: (b)(6) 2016, product type: catheter.
Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 19-oct-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 consumer regarding a patient receiving fentanyl and bupivacaine at unknown concentrations and doses via an implantable infusion pump.
The indication for use was noted to be non-malignant pain.
It was reported that the patient had been having "problems" and her pump was replaced on (b)(6) 2019.
She clarified the problems as "the catheter was doing something when she would give herself a bolus - her left leg would go dead" and she would have to drag her leg when she walked.
This began about 6 months prior to the report date.
She also noted that her doctor told her she had a granuloma at the end of the catheter for the past couple of weeks, relative to (b)(6) 2019, but "a few days ago" the doctor said he now didn't think it was a granuloma but a "narrowing of the spinal cord" and he wanted to "go in and take out a vertebrae" but instead he replaced the patient's pump.
The catheter was left in place.
After the replacement the patient noted that from her waist down goes numb and she "falls to the floor.
" she had pain from head to toe and her "right leg was giving her problems.
" she noted she was seeing her doctor on (b)(6) 2019 for a refill.
She was going to bring her concerns up to him then.
No further complications were reported.
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