Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.During the processing of this complain, attempts to obtain patient information were attempted, but not received.
|
Related manufacturer report number: 3006705815-2021-00521, 1627487-2021-01100, 1627487-2021-01101, 1627487-2021-01102.It was reported the patient presented to the emergency room on (b)(6) 2021 due to drainage at the ipg site.The patient was then given antibiotics and sent home, but the drainage continued.It was noted that the there was a small area on the incision that did not close and would scab and heal.The patient then presented to the hospital on (b)(6) 2021 due to increased pain at the anchor and lead sites.As a result, the patient underwent surgical intervention during which the system was explanted.
|