Continuation of medical devices: product id 977a260, serial# (b)(4), implanted:(b)(6) 2017, product type lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 977a260, serial/lot #: (b)(4), ubd: 31-jul-2021, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 31-jul-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Information was received via a manufacturer representative from a consumer regarding a patient who was implanted with a neurostimulator.It was reported that the patient had an increase in pain but denied any falls or non-compliance to restrictions.The patient has had multiple reprogrammings to try and diagnose the issue, and the impedances checked were normal.X-rays were taken, and the images showed that the leads had moved.The manufacturer representative reprogrammed using the evolve workflow corresponding to the new images obtained, but the issue was not resolved at the time of the report.Surgical intervention was not performed and was not planned.There were no further complications reported.
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