Model Number SC-2218-70 |
Device Problems
High impedance (1291); Unexpected Therapeutic Results (1631)
|
Patient Problem
Inadequate Pain Relief (2388)
|
Event Date 01/20/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the patient experienced inadequate stimulation due to high impedances.It was attempted to cover the pain area by reprogramming around the high impedances, but reprogramming was not successful.The patient underwent a revision procedure in which the lead was replaced.The patient is doing well post operatively.
|
|
Manufacturer Narrative
|
Approximated based on the date the manufacturer became aware of the event.
|
|
Manufacturer Narrative
|
Block b3: approximated based on the date the manufacturer became aware of the event.The returned lead was analyzed and visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the fracture location.The lead got kinked after it exits the clik anchor resulting in the reported complaint.A labeling review was performed on the lead instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.Based on all available information, engineers were able to confirm the root cause of the inadequate stimulation due to the high impedances on the lead.The production record review, database analysis, and device technical analysis revealed no product issues.However device analysis of the lead confirmed the root cause as traced to component failure.
|
|
Event Description
|
It was reported that the patient experienced inadequate stimulation due to high impedances.It was attempted to cover the pain area by reprogramming around the high impedances, but reprogramming was not successful.The patient underwent a revision procedure in which the lead was replaced.The patient is doing well post operatively.
|
|
Search Alerts/Recalls
|