microTargeting Depth Stop Adapter; microTargeting STar Drive System (Manual); microTargeting STar Drive System (Motorised); microTargeting Drive System; microTargeting STar Drive System (Manual) 의 리콜

Recall

RC-2018-RN-00663-1

Class II

2018-06-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00663-1

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.

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.