Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Impaired Healing (2378); Fluid Discharge (2686)
|
Event Date 05/03/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
|
|
Event Description
|
It was reported the patient's scs lead site was not healing properly.A company representative met with the patient and the patient stated there was drainage at the lead incision site.The patient was prescribed antibiotics and a topical medication to address the issue.Follow up identified the patient's issue was improving but not healed.
|
|
Event Description
|
Follow up information received identified the patient's scs lead implant wound has healed.
|
|
Search Alerts/Recalls
|