Information was received from a healthcare provider (hcp) of a clinical study regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported there was a dehisced incisional wound at the right shoulder ins incision site.The issue was resolved without sequelae on (b)(6) 2019.The patient was on a course of antibiotics for 10 days - bactrim starting (b)(6) 2019.It was noted there was other surgical intervention, as sharp tissue excisional debridement of the right shoulder ulcer at the incision site.It was noted, however, the procedure was not related to the device.It was indicated the event was unrelated to the device/therapy, but it was related to the implant procedure.Symptoms were noted as some pus-like formation at right shoulder generator surgical site,.Drained some white thick matter even after course of antibiotics for ten days.Debridement of ulcer for removal necrotic tissue.An infection was suspected at the incision site, cbc, esr, and crp were little elevated.No further complications were reported.
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