Model Number 3662 |
Device Problem
Premature End-of-Life Indicator (1480)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 12/11/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
It was reported that the end of service message appeared for the ipg.It is unknown if the indicator triggered earlier than intended.It was noted that the patient had lost stimulation after receiving the message.As a result, the patient underwent surgical intervention during which the ipg was explanted and replaced.Effective therapy was established post-operatively.
|
|
Manufacturer Narrative
|
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
|
|
Search Alerts/Recalls
|