If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor. It was reported that the patient had a return of symptoms ever since they got bronchitis, pneumonia, and fluid in their ears. The patient stated they felt like they were back to square one and it was not doing them any good. The patient wanted to increase stimulation. Syncing with the programmer showed stimulation was on and the patient increased stimulation from 0. 6 to 0. 7 where they felt stimulation comfortably. It was noted that the patient had an appointment scheduled in (b)(6) 2020.? Additional information was received from a consumer indicating that the patient? S ins worked? Some at first? To resolve their symptoms but it had gotten worse since? After (b)(6).? The patient stated they go to the bathroom and can't do nothing but then they leave the bathroom, coughs, and leaks. The patient noted having copd, so they cough a lot and leaks with the coughs. The patient noted being sick all of january, having shots, x-rays, and antibiotics for over a month. The patient noted an appointment with their healthcare provider the following day to go over therapy adjustments and that stimulation was increased to 1. 1 at their last one. The patient was redirected to their healthcare provider. Additional information was received from a consumer. It was reported that they went back on allergy pills and when they woke up their leg was hurting them and it was like they had to pee, but they couldn't pee. It was stated that the same thing happened on the morning of (b)(6) 2020. They also stated that they were leaking an awful lot, and their bladder sill didn't want to empty all the way, and that that had been going on since implant. It was mentioned that they always felt stimulation at 1. 3 so they were assisted with changing to program 6 at 1. 0 where they could feel stimulation. It was recommended that they monitor their symptoms after making the change and follow up with their healthcare provider if not resolved. The patient called back two days later reporting the same issues, with emptying the bladder and leaking, and that the changes made last time had not resolved or improved their symptoms. It was recommended that they follow up with their healthcare provider. No further patient complications are anticipated or expected as a result of this event.
Patient Sequence No: 1, Text Type: D, B5