SenSight™ B3300542MRecalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00763000426408), received between Jul 19, 2021 and Sep 29, 2026 — classified as 3 deaths, 37 injuries, 75 malfunctions.

The most frequently reported specific device problem is “High impedance” (31 reports).

20 other recalls cover devices cleared under the same FDA submission (H020007, P960009); 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 25 most recent of 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  It was reported that lead was identified as bent before implant - surgeon asked for replacement. No known external factors contributed to this issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933218 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Intracranial Hemorrhage

  MAUDE report 50841962 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had surgery in April and there was a complication during surgery, an intracranial hemorrhage so patient was in rehab for 3 months so the process has been very challenging, they are just getting started learning about the equipment. Additional information received from HCP confirming intracranial hemorrhage was related to implant of bilateral intracranial DBS leads for treatment of Parkinson's disease including ICU stay to determine if from MER microelectrode or macro. Implant surgery occurred on (b)(6) 2026. Supportive care was given to address this, patient is reported to be improving.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 50841902 ↗
• MalfunctionSep 18, 2026Break

  It was reported that the electrode was damaged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817863 ↗
• MalfunctionAug 19, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50328033 ↗
• MalfunctionJul 9, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25770438 ↗
• MalfunctionMay 4, 2026High impedance

  IT WAS REPORTED THAT IMPEDANCE ISSUES DISCOVERED DURING PROCEDURE. IT HAS BEEN KNOWN FOR THIS SURGEON TO USE A CANNULA WHICH CAUSES AIR BUBBLES TO BE TRAPPED AND CAUSED TEMPORARY HIGH OUT OF RANGE IMPEDANCE. DURING THIS PROCEDURE, THE SURGEON USED THE SAME CANNULA TYPE. IMPEDANCE TESTS WERE RUN WITH THE FULL SYSTEM VERSUS USING A LEAD TEST CABLE TO TEST THE LEADS AND TROUBLESHOOTING DURING THE PROCEDURE CLEANING CONTACTS AND ENSURING PROPER FIT AT EACH CONNECTION SITE. THE FIRST IMPEDANCE TEST WAS PERFORMED AFTER IPG IMPLANTATION, AND NOT BEFORE THE LEAD WAS SECURED IN STAGE ONE. HISTORICALLY, PATIENTS HAVE IMPEDANCE ISSUES THAT CLEAR WITHIN A DAY OR SO. THIS PATIENT WILL NOT BE CHECKED UNTIL THE TWO WEEK POST SURGICAL FOLLOW UP THEREFORE A REPORT WAS WARRANTED. IT IS POSSIBLE THAT THE IMPEDANCE WILL BE WITHIN NORMAL LIMITS AT THAT FOLLOW UP. ADDITIONAL INFORMATION RECEIVED FROM REP THAT FOLLOW UP APPOINTMENT IS SCHEDULED FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072788 ↗
• MalfunctionApr 24, 2026High impedance

  IT WAS REPORTED THAT EXCESSIVELY HIGH LEAD IMPEDANCE WAS IDENTIFIED INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978979 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT A LEAD FRACTURE WAS DISCOVERED DURING THE SURGERY. THE LEAD WAS REPLACED WITH A NEW LEAD ON THE SAME DAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953512 ↗
• MalfunctionApr 10, 2026Material Twisted/Bent; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE MEASURING THE LEAD, THE PHYSICIAN PULLED BACK THE STYLET ABOUT 1.5 INCHES AND THE LEAD SHIFTED AND THE LEAD TIP BENT AS THE STYLET WAS REMOVED. THE SAME ISSUE OCCURRED WITH A SECOND LEAD, WITH LEAD SHIFTING AND THE TIP BENDING DURING STYLET REMOVAL. A THIRD LEAD WAS USED AND DID NOT HAVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844875 ↗
• MalfunctionApr 10, 2026Material Twisted/Bent; Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE MEASURING THE LEAD, THE PHYSICIAN PULLED BACK THE STYLET ABOUT 1.5 INCHES AND THE LEAD SHIFTED AND THE LEAD TIP BENT AS THE STYLET WAS REMOVED. THE SAME ISSUE OCCURRED WITH A SECOND LEAD, WITH LEAD SHIFTING AND THE TIP BENDING DURING STYLET REMOVAL. A THIRD LEAD WAS USED AND DID NOT HAVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844200 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STATE ONE PROCEDURE WAS COMPLETED AND POST-OP CT SCAN LOOKED GREAT. SHORTLY AFTER, HOWEVER, THE PATIENT'S REPRESENTATIVE REPORTED THAT THE PATIENT HAD CONFUSION AND TROUBLE WITH WORD FINDING. A SECOND CT SCAN WAS COMPLETED AND HEALTHCARE PROVIDER (HCP) OBSERVED SEVERE PERI-LEAD EDEMA. CAUSE WAS UNKNOWN AT THE TIME OF THE REPORT. STAGE TWO PROCEDURE WAS PLANNED.

  Patient problems: Cognitive Changes; Confusion/ Disorientation; Swelling/ Edema

  MAUDE report 24780867 ↗
• MalfunctionMar 25, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT DURING INTRAOPERATIVE TESTING FOR A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD EXHIBITED ALTERED IMPEDANCE, WHICH PREVENTED THE NECESSARY INTRAOPERATIVE TESTS FROM BEING PERFORMED. THE LEAD WAS REPLACED, AND THE PROCEDURE CONTINUED NORMALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687594 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT A LEAD FRACTURE WAS DISCOVERED DURING THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629640 ↗
• MalfunctionMar 17, 2026Migration or Expulsion of Device; Unstable

  IT WAS REPORTED THAT BURR HOLE DEVICE CLIP WAS VERY DIFFICULT TO SECURE. IT KEPT POPPING OUT AND THE JAW KEPT OPENING. THIS CAUSED THE LEAD TO GO 8 MM DEEPER THAN ORIGINALLY SET. HEALTHCARE PROVIDER (HCP) HAD TO GET REPEATED LOW DOSE MEDIUM THICKNESS SCANS LOW-UNTIL HE WAS ABLE TO GET THE LEAD BACK TO THE ORIGINAL POSITION. HE WAS THEN ABLE TO RESECURE THE CLIP AND CAP. IMAGING WAS USED TO GET LEAD BACK INTO ORIGINAL POSITION. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622171 ↗
• MalfunctionMar 17, 2026High impedance

  IT WAS REPORTED THAT WHEN IT CAME TIME TO TEST IMPEDANCES ON THE LEAD WITH THE LEAD TEST CABLE, IMPEDANCES WERE HIGH FOR SEGMENT 1B ON THE LEAD. AT THIS TIME MANUFACTURER REPRESENTATIVE (REP) CHECKED WITH THE SURGEON THAT THE STYLET WAS ALL THE WAY IN THE LEAD, AND REP HAD HIM MAKE SURE THE TEST CABLE WAS FULLY SLOTTED OVER THE END OF THE LEAD. REP ALSO HAD HEALTHCARE PROVIDER (HCP) REMOVE THE TESTING CABLE AND PLACE IT BACK ON WHILE RERUNNING IMPEDANCES IN BETWEEN. EACH TIME REP RAN AN IMPEDANCE MEASUREMENT THE SAME RESULT OF HIGH IMPEDANCES ON SEGMENT 1B OCCURRED. AT THIS TIME REP ALSO HAD THE SURGEON HOOK UP THE MONOPOLAR TESTING CABLE SO THAT THEY COULD ADD STIM DIRECTLY TO THE SEGMENT THAT WAS SHOWING HIGH IMPEDANCES TO SEE IF THERE WAS ANY FLUID AROUND THE LEAD THAT NEEDED TO BE FLUSHED. EVEN AFTER TRYING THIS, THE IMPEDANCES STILL DID NOT CLEAR FOR SEGMENT 1B. AFTER TROUBLESHOOTING AND NOT CLEARING IMPEDANCES IT WAS DECIDED BEST TO GET A NEW LEAD FOR IMPLANT. THE NEW LEAD CLEARED THE IMPEDANCE ISSUE AND REMAINED IMPLANTED FOR THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622117 ↗
• MalfunctionFeb 9, 2026Component Missing

  IT WAS REPORTED THAT SURGEON SAID LEAD END CAP WAS NOT INCLUDED WITH LEAD. TROUBLE SHOOTING INCLUDED OPENING UP THE WRENCH AND CAP ACCESSORY KIT. MANUFACTURER REPRESENTATIVE (REP) REPORTS THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24295697 ↗
• InjuryFeb 6, 2026High impedance

  CAUSE REMAINS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278055 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT VISITED WITH NEUROSURGEON; IT WAS DECIDED THAT PATIENT HAD ACTIVE INFECTION AND EQUIPMENT NEEDED TO BE EXPLANTED. PATIENT WENT IN FOR SURGERY ON 1/6/26 TO EXPLANT BOTH LEADS. PATIENT IS ALIVE WITH NO ADDITIONAL INJURY; OUTCOME OF THE INFECTION IS UNKNOWN AT THIS. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT HCP WILL WAIT 3-6 MONTHS FOR INFECTION TO CLEAR BEFORE CONSIDERING REIMPLANTING. IT IS NOT KNOWN IF THE INFECTION IS YET RESOLVED. NO OTHER MANUFACTURER DEVICES WERE INVOLVED IN THE EXPLANTATION. DEVICES WERE DISCARDED AFTER SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 24133378 ↗
• InjuryDec 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE ON CONTACT ONE WERE DISCOVERED DURING INTEROPERATIVE TESTING AT 10K OHMS. HAD THE SURGEON RECONNECT AND DISCONNECT LEAD SEVERAL TIMES FROM THE LEAD TEST CABLE, EACH TIME SHOWING THE SAME ISSUE. IT WASN¿T UNTIL WE REPLACED THE LEAD WITH A NEW MANUFACTURER LEAD THAT ISSUE RESOLVED. PATIENT IS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849815 ↗
• InjuryDec 9, 2025Break; Malposition of Device; Break; Malposition of Device

  IT WAS REPORTED THAT THERE WAS AN EXPLANT SURGERY SCHEDULED FOR TODAY TO REMOVE LEFT LEAD DUE TO NOT OPTIMAL PLACEMENT. FIRST NOTIFIED TODAY ((B)(6) 2025) OF THE PROCEDURE. DURING THE PROCEDURE LEAD WAS OBSERVED BY HCP AS DAMAGED, REPORTED BY SURGEON, IMPEDANCES POST OP ALL WITHIN NORMAL RANGE. HCP WOULD LIKE ANALYSIS OF LEAD AS SHE DID NOT DAMAGE LEAD DURING PROCEDURE. PLASMA BLADE WAS USED. SURGEON WAS CAREFUL NOT TO DAMAGE LEAD DURING EXPLANT. HCP WAS CAREFUL NOT TO BREAK LEAD DURING EXPLANT PROCEDURE AND BELIEVES THE BREAK IN THE LEAD WAS PRESENT BEFORE EXPLANT SURGERY. IMPEDANCES PRE OP WHERE WITHIN NORMAL RANGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757773 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE END (DISTAL BRAIN CONTACT END) OF THE LEAD WAS SLIGHTLY BENT OUT OF THE BOX PRIOR TO USE. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS WERE IDENTIFIED AS CONTRIBUTING TO THE ISSUE. THE PRODUCT WAS NEVER IMPLANTED. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. A REPLACEMENT LEAD WAS PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23637420 ↗
• MalfunctionNov 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS UNABLE TO PASS THE CONNECTIVITY TEST, DESPITE TRYING MULTIPLE EXTERNAL NEUROSTIMULATORS (ENS), LEAD TEST CABLES, AND TWO TABLETS, WITH THE SAME RESULT EACH TIME. TECHNICAL SERVICES REVIEWED WITH THE REPRESENTATIVE THAT THE IMPEDANCES WERE GREATER THAN 5K OHMS, AND AS LONG AS THE IMPEDANCE REMAINS HIGH, THE CONNECTIVITY TEST WILL NOT PASS. REPLACING THE LEAD RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE INDICATING THAT THE ISSUE OCCURRED DURING THE FIRST IMPLANT SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590495 ↗
• MalfunctionAug 25, 2025Material Twisted/Bent; Material Twisted/Bent

  H.11

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883957 ↗
• MalfunctionAug 14, 2025Material Twisted/Bent; Material Twisted/Bent

  SEE H.11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22801422 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, P960009. One submission often covers many models, so check the product and lot details in each record.

• Z-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
• Z-1617-2015 · Apr 16, 2015 · Terminated
  Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
• Z-0279-2014 · Sep 30, 2013 · Terminated
  Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Z-1190-2013 · Feb 8, 2013 · Terminated
  Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del

…and 5 more.