Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Stroke/CVA (1770); Fall (1848); Numbness (2415)
|
Event Date 09/16/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.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 presented to the er 5 days after permanent implant (b)(6) 2018) due to a fall caused by right leg numbness.Reportedly, x-ray images were ordered to determine lead integrity.Follow-up identified the patient was hospitalized and diagnosed with a mini stroke.No additional information regarding the issue nor patient status has been made available at time.
|
|
Event Description
|
Additional follow-up identified the numbness in the right leg has resolved.Reportedly, the issue was related to a stroke and not the device.Furthermore, the patient's receiving effective therapy from their scs system.
|
|
Search Alerts/Recalls
|