Per the clinic, the patient experienced an infection, pain and erythema at the implant site (specific date not reported).The patient was treated with antibiotics via parenteral route (specific date, type and duration not reported), however, the issue did not resolve.The patient was hospitalized on (b)(6) 2023, for iv antibiotics administration and the device was explanted on (b)(6) 2023.There are no plans to reimplant the patient with a new device as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.
|