| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00422-1 |
| Product Name/Description |
DBS Lead Depth Stop
DBS Lead Depth Stop supplied with Medtronic Models 3387, 3389 and 3391
All leads with a use by date of 2021-03-01 or earlier
ARTG Numbers: 137374, 137138 and 174469 respectively |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic have received three complaints from physicians regarding the DBS depth stop not being adequately secured to the lead. In two of the three complaints received, this resulted in initial DBS lead placement beyond the intended target, which was identified via intraoperative imaging and corrected with no report of patient harm. In the third instance, the issue was identified prior to lead insertion.
Analysis of these returned products indicate the threaded area of the depth stop screw did not extend far enough to allow it to fully secure the lead in the depth stop causing the slippage of the lead through the depth stop. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic is requesting surgeons who suspect that the depth stop is not tightening adequately onto the lead to discontinue use the affected device but instead, to complete the procedure using a depth stop from another Medtronic DBS lead kit. Surgeons are further requested to check the stimulation effect during the implant procedure and use imaging techniques to confirm lead placement, as stated in the DBS lead implant manual. For devices already implanted, surgeons are advised that no action is needed (since lead placement at the intended target location is expected to have been confirmed through intraoperative test stimulation, imaging, and/or therapy effectiveness).
This action has been closed out on 22/10/2018 |
| Contact Information |
1800 652 972 - Medtronic Neuromodulation Services |