NEXDRIVE™ MI-2000 (UDI 00643169986770)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169986770), received between Jan 7, 2020 and Jan 7, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K022100); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 9, 2019Terminated

   Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).

   Z-1995-2020 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED BY A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING IMPLANT, THE HCP WAS USING THE NEXFRAME AND WHEN THE CANNULA WAS PLACED IN THE MEDIAL/RIGHT ENTRY, IT WAS VERY TIGHT. THERE WAS NO OUT OF BOX FAILURE REPORTED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9560282 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022100. One submission often covers many models, so check the product and lot details in each record.

• Z-2118-2014 · Jun 11, 2014 · Terminated
  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 micr
• Z-0849-2008 · Oct 4, 2007 · Terminated
  Nexframe Stereotactic System Kits, Model Number(s): DB-1021-MR, DB-1031, DB-1040-BL, DB-1040-ST, DB-1041, DB-1041-BL, DB-1041-ST, DB-1042, DB-1042-BL, DB-1042-ST, DB-1043, DB-1043-