| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00663-1 |
| Product Name/Description |
microTargeting Depth Stop Adapter
Product Model Number: 66-AC-DS(1.8)
microTargeting STar Drive System (Manual)
Product Numbers: ST-DS-MA and 70-ZD-MA
microTargeting STar Drive System (Motorised)
Product Numbers: ST-DS-ME and 70-ZD-ME
microTargeting Drive System
Product Numbers: FC1006 and 9033G0601
microTargeting STar Drive System (Manual)
Product Number: FC8001
ARTG Number: 177545
(Emergo Asia Pacific Emergo Australia - Stereotactic surgery system, neurological) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
During a DBS lead implant procedure, the FHC Depth Stop Adapter is placed onto the lead to set the desired distance to target. The Depth Stop Adapter then mounts in the Lead Measurement Fixture to ensure that the lead is not inserted beyond the targeted depth. The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperatively or in a follow-up procedure. Recent reports of lead short circuit events have led to an improvement of the depth stop design and a recall the previous version of this product.
To date, there have been no reports of patient death related to this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
Emergo is advising FHC and Medtronic Field Representatives will review user's inventory and replace affected Depth Stop Adapters on hand with an improved design.
In the interim, Emergo advise that users do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Emergo Australia, or their local field rep.
This action has been closed out on the 06/12/2018. |
| Contact Information |
02 9006 1662 - Emergo Australia |