|
Model Number 11823 |
Device Problem
Use of Device Problem (1670)
|
Patient Problem
Pain (1994)
|
Event Date 08/20/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit and sub assembly, verification of all final testing performed by/on the catheter kit and sub assembly, verification of sterilization, and packaging for subject catheter kit and sub assembly was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit and sub assembly function.Device was not returned.It was determined that the patient's reported pain after the initial implant was likely related to the physician inadvertently pinning the nerve.Internal complaint number: (b)(4).
|
|
Event Description
|
Representative reported that following implant surgery, the patient reported pain after waking up.The physician believed they had inadvertently pinned a nerve and decided to take the patient back into surgery.The pump was turned off and the catheter was removed from the intrathecal space.The catheter was coiled, tied off, and left inside the patient.The physician put the patient on oral medication and about a month later, brought the patient back in for surgery.The physician cut the coiled catheter out, put in a revision barb, and inserted catheter into intrathecal space.
|
|
Search Alerts/Recalls
|
|
|