Per the clinic, the patient experienced granulation tissue near incision site and was hospitalized and placed on iv medication (type not reported) in (b)(6) 2019.On (b)(6) 2019 the patient underwent revision surgery to excise skin at implant site, however, the issue of granulation and swelling persisted resulting in further hospitalisation on (b)(6) 2020.It was found during hospitalisation that the electrode array had extruded.The device was explanted on (b)(6) 2020.It is unknown if the patient was re-implanted with a new device during the same surgery.
|