Model Number SC-1132 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Irritation (1941); No Code Available (3191)
|
Event Date 03/22/2019 |
Event Type
Injury
|
Event Description
|
A report was received that the patient was experiencing irritation at the ipg site.Database analysis revealed no anomalies.The patient underwent a revision procedure wherein the ipg was replaced and the pocket site was relocated.The patient was doing well postoperatively.
|
|
Manufacturer Narrative
|
(b)(4), sn (b)(6).The returned ipg was analyzed and the device passed the current leakage test and residual gas analysis.With all the available information, boston scientific concludes that the root cause of pocket irritation could not be determined.The patient had lost weight which typically results in the reduction of the implant depth in the pocket causing the ipg to be felt closer to the surface of the skin.The probable cause selected is adverse event related to patient condition.
|
|
Event Description
|
It was reported that the patient was experiencing irritation at the ipg site.Database analysis revealed no anomalies.The patient underwent a revision procedure wherein the ipg was replaced and the pocket site was relocated.The patient was doing well postoperatively.
|
|
Search Alerts/Recalls
|