Nexdrive™ MI-1000 (UDI 00613994747853)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994747853), received between Apr 28, 2017 and Aug 30, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2018Device Damaged Prior to Receipt by User; Insufficient Device Problem Information; Device Damaged Prior to Receipt by User; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP)VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) IT WAS REPORTED THAT SET SCREW IN THE MEASURING TOOL WAS BROKEN IN THE PACKAGE. A NEW MEASURING TOOL WAS OPENED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7832799 ↗
• MalfunctionJul 13, 2018Fitting Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED DURING THE PROCEDURE THE TUBE COLLET ON THE NEXDRIVE WAS VERY TIGHT WHILE INSERTING THE ALPHA OMEGA MICRO CANNULA. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE THOUGHT TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN WAS ABLE TO INSERT THE TUBE CORRECTLY BUT NOTED A VERY TIGHT FIT MUCH MORE THAN USUAL. NO TROUBLESHOOTING WAS DONE AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7686941 ↗
• MalfunctionApr 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE ABOUT A PATIENT BEING IMPLANTED WITH DBS THERAPY FOR UNKNOWN SYMPTOMS. IT WAS REPORTED THAT DURING THE PATIENT¿S IMPLANT PROCEDURE THE MICRO ELECTRODE RECORDING (MER) COLLAR HAD A TIGHT HOLE THAT WOULD NOT ALLOW THE MER TO PASS THROUGH. THE IMPLANTING SURGEON USED A DIFFERENT MER COLLAR THAT COMES IN THE KIT TO FINISH THE SURGERY WITHOUT A PROBLEM. THERE WERE NO SYMPTOMS REPORTED. NO COMPLICATIONS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6530305 ↗

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-