Model Number 3186 |
Device Problem
Difficult to Remove (1528)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/28/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Sjm 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.Sjm defers to the patient's physician regarding medical history.
|
|
Event Description
|
It was reported during the patient's scs system permanent procedure the pre-loaded stylet would not come out after the lead was placed.The physician used a clamp to pull and stylet and lead began to bunch up and crimp.The physician removed the lead and a new lead was placed to complete the procedure.In addition, the procedure was reportedly extended for over an hour.
|
|
Manufacturer Narrative
|
(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.
|
|
Search Alerts/Recalls
|