Model Number 6172 |
Device Problem
Component Misassembled (4004)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
A corrective/preventive action plan has been initiated by the manufacturer to address this issue.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
|
This report is related to a (b)(6) patient.It was reported that intra-operative fluoroscopy indicated one of the contacts of an infinity dbs (deep brain stimulation) lead was lighter than the other contacts.The lead remains implanted, however no consequences or impact to the patient have been reported.
|
|
Event Description
|
Additional information received indicated the radiograph is confirmed to be the incorrect material; therefore, the material segregation issue described in fsca 1627487-10/16/18-001-r did affect this lead.The programming history review was performed and no evidence of therapeutic programming on the most proximal unsegmented electrode was found.Stimulation parameters did not activate the most proximal electrode and that electrode is constructed out of a known biocompatible material, aside from maintaining the programming restriction there is no additional action necessary for this patient.
|
|
Search Alerts/Recalls
|