NexdriveRecalls & reported problems across all models
Medtronic, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of Nexdrive by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Apr 28, 2017 and Jan 7, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Nexdrive recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Nexdrive problems
Device problems
- Insufficient Device Problem Information3
- Device Operates Differently Than Expected2
- Break1
- Device Damaged Prior to Receipt by User1
- Fitting Problem1
Patient problems
- No Known Impact Or Consequence To Patient5
Nexdrive models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NEXDRIVE™ MI-2000Neurological stereotaxic Instrument1 recall1 report
- NEXDRIVE™ MI-1000Neurological stereotaxic Instrument1 recall0 reports
- Nexdrive™ MI-1000Neurological stereotaxic Instrument3 reports
- Nexdrive™ MI-2000Neurological stereotaxic Instrument1 report
Recent Nexdrive adverse event reports
The 5 most recent reports across all models, 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 ↗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 ↗MalfunctionSep 7, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected
A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE MEASUREMENT TAPE WAS MISALIGNED ON THE MICRO-POSITIONING SYSTEM. THE MISALIGNMENT BETWEEN RED AND BLUE COLOR WAS NOT EXACTLY AT ZERO. NO TROUBLESHOOTING OR DIAGNOSTICS WERE REPORTED. NO ACTIONS WERE TAKEN TO RESOLVE THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO MEDICAL SYMPTOMS WERE REPORTED. THE PATIENT WAS IMPLANTED FOR UNKNOWN SYMPTOMS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6849814 ↗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 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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