Device product
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
Z-2118-2014
Product summary
- Event
- Event 68615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 EXPANDED 10/02/2014 130 devices
- Official record key
device-enforcement:Z-2118-2014
Official wording
Reason: Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
Code information: Lot numbers: 082605614, 082601414, 082602014, 082634313, 082630913, 082629713, 082629613, 082626913, 082623113, 082621413, and 082618213. EXPANDED 10/02/2014 Lot Numbers: 082616214, 082616314, 082618314, and 082618414.
Distribution pattern: Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom.
Derived failure modes
-
Unknown
Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.