Model Number 3788 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Pain (1994)
|
Event Type
Injury
|
Manufacturer Narrative
|
This ipg serial number was included in a field advisory.(b)(4).
|
|
Event Description
|
It was reported the patient is experiencing pain/tenderness at the ipg site since losing weight.It was noted the physician assessed the site and found no anomalies.However, the patient may undergo surgical intevention as the next course of action.
|
|
Event Description
|
Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2016, where the ipg was explanted and replaced with different model.Surgical interventon resolved the reported issue.
|
|
Search Alerts/Recalls
|