microTargeting™ Electrode FC2002-00750Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10873263007508), received between Aug 19, 2020 and Oct 14, 2020 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADVERSE EVENT INVOLVING FHC MT ELECTRODE & TUBES OCCURRED DURING A CASE ON (B)(6) 2020. THE EVENT WAS DESCRIBED AS FOLLOWS: AFTER SINGLE PASS MER THE SURGEON ADVANCED THE MICROELECTRODE TO THE VIM TARGET AND THE PATIENT BEGAN TO SLUR HIS SPEECH. THERE WAS NO STIMULATION RUNNING AT THE TIME. HCPS DECIDED TO DISCONTINUE WITH PLAN TO TEST STIM AND REMOVED THE MICRO ELECTRODE AND IMPLANTED A 3387. THE ISSUE WAS NOT WITH THE DEVICE, IT WAS JUST THE DEVICE THAT WAS BEING USED AT THE TIME THE ISSUE OCCURRED. PATIENT WAS CONSCIOUS AND ABLE TO TALK, BUT HAD SLURRED SPEECH A THE END OF THE PROCEDURE. POSSIBLE STUN EFFECT. PATIENT UPDATE: THE PATIENT STILL HAS SLIGHTLY SLURRED SPEECH BUT IS IMPROVING. THIS HAS BEEN CONFIRMED WITH THE PHYSICIAN."

  Patient problems: Speech Disorder

  MAUDE report 10676753 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF THE DEEP BRAIN STIMULATOR (DBS) TO LEFT GPI FOR DYSTONIA. FIVE YEARS AGO THEY WERE IMPLANTED BILATERALLY STN FOR PARKINSON'S DISEASE. THE PROCEDURE WAS COMMENCED AS PER USUAL, BURR HOLE PERFORMED MER. NOTHING WAS NOTED TO BE UNUSUAL. INTRA-OPERATIVE XRAYS PERFORMED. ON REMOVAL SMALL AMOUNTS OF BLOOD IN MER CANNULA WERE OBSERVED. THE LEAD WAS IMPLANTED AND AN X-RAY WAS PERFORMED. LEADS FROM PREVIOUS IMPLANT OBSERVED THAT ONE WAS DISPLACED. CURVATURE WAS EVIDENT. A CT WAS PERFORMED AND A LARGE BASAL GANGLIA HAEMATOMA WAS EVIDENT WITH A MID LINE SHIFT. THE PATIENT RETURNED TO THE OPERATING ROOM AND A EMERGENCY VENTRICULAR CATHETER WAS INSERTED AND EXTERNAL VENTRICULAR DRAIN WAS ATTACHED. CSF WAS DRAINED. NO OBVIOUS BLOOD STAINING EVIDENT. BOTH PUPILS WERE REACTIVE AND THE PATIENT REMAINS INTUBATED. THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT. THE ISSUE IS NOT YET RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE HEMATOMA WAS ATTRIBUTED TO THE INSERTION OF THE MER ELECTRODE WHICH IS BELIEVED TO HAVE RUPTURED A VESSEL, CAUSING THE BLEED; AND THEREFORE THE SWELLING FROM HEMATOMA IMPACT THE INSTALLED LEAD CAUSI

  Patient problems: Hematoma

  MAUDE report 10425577 ↗