Patient dob (b)(6) had her device replaced because the impedance was out of range.Dr.Implanted the device she is replacing on (b)(6) 2022.On (b)(6) 2024 device was interrogated with and was found to have an impedance out of range >800.On (b)(6) 2024 patient underwent surgery to identify issue with system.Dr.Tried tightening the set screws and the impedance normalized.Dr.Switched out the device because she didn't want the same issue to happen again.The replacement new devices serial number is (b)(6).The removed devices serial number is (b)(6).The set screw is suspected to have loosened over time.The removed device is being sent in for analysis to medtronic.
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