SenSight™ B3400060Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00763000426477), received between Jan 21, 2022 and Jul 1, 2026 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “High impedance” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026High impedance

  IT WAS REPORTED THAT UNEXPLAINED ABNORMAL IMPEDANCE VALUES WERE OBSERVED DURING EVALUATION OF THE IMPLANTED SYSTEM. TROUBLESHOOTING STEPS INCLUDED SWITCHING THE EXTENSION CONNECTION AT THE IMPLANTED PULSE GENERATOR; HOWEVER, THE ELEVATED IMPEDANCE VALUES REMAINED ON THE SAME SIDE. THE EXTENSION WAS THEN REMOVED, CLEANED, DRIED, AND REINSERTED AT BOTH THE GENERATOR AND CRANIAL CONNECTION POINTS, BUT HIGH IMPEDANCE VALUES PERSISTED ACROSS ALL CONTACTS. A NEW EXTENSION WAS SUBSEQUENTLY CONNECTED, AFTER WHICH IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS. NO ENVIRONMENTAL OR PATIENT-RELATED CONTRIBUTING FACTORS WERE IDENTIFIED, AND THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT OF THE EXTENSION. THE HEALTHCARE PROFESSIONAL REPORTED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25676235 ↗
• MalfunctionMay 28, 2026High impedance

  IT WAS REPORTED THAT EXTENSION HAD ELEVATED IMPEDANCE AT CONTACT 2 SEGMENT B INTRAOPERATIVELY. MULTIPLE IMPEDANCE MEASUREMENT TAKEN. DISCONNECTED AND RECONNECTED EXTENSION AND BATTERY MULTIPLE TIMES. EXTENSION REPLACED, ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317496 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT SURGEON WAS TUNNELING 3 EXTENSION WIRES AT ONCE. HE WAS INFORMED THAT THIS WAS OFF LABEL. HE INSERTED TWO EXTENSION WIRES INTO THE TUNNELER CARRIER PROPERLY. THE THIRD EXTENSION WIRE WAS TIRED TO THE END OF THE CARRIER WITH A SUTURE. AGAIN, HE WAS INFORMED THIS WAS OFF LABEL. AS HE WAS PULLING THE TUNNELER FROM THE CHEST POCKET THROUGH TO THE HEAD POCKET, EXTENSION WIRES BECAME STUCK ON TISSUE CAUSING THE TWO EXTENSION WIRES IN THE CARRIER TO BECOME FRAYED. THE WHITE SHEATH WAS STRIPPED BACK EXPOSING THE INTERNAL WIRES AND COMPLETELY COMPROMISING THE WIRES. THE THIRD EXTENSION WIRE REMAINED INTACT. NEW EXTENSION WIRES WERE OPENED AND IMPLANTED TO REPLACE THE BROKEN WIRES. THE SURGEON REQUESTED AN OFF LABEL SHUNT TUNNELER. HE PASSED EACH EXTENSION WIRE THROUGH A HOLLOW TUBE. ALL IMPEDANCES WERE NORMAL. MANUFACTURER REPRESENTATIVE (REP) INDICATES THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117431 ↗
• MalfunctionMar 12, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE EXTENSION EXHIBITED HIGH IMPEDANCE. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE EXTENSION WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24584566 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE EXTENSION SNAPPED OFF AT THE IMPLANTABLE PULSE GENERATOR END WHILE BEING INSERTED INTO THE IMPLANTABLE PULSE GENERATOR. THE BROKEN EXTENSION, INCLUDING THE TIP THAT SNAPPED OFF, WAS REMOVED AND REPLACED WITH A NEW EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474432 ↗
• MalfunctionFeb 23, 2026High impedance

  IT WAS REPORTED THAT DURING A STAGE 2 DEEP BRAIN STIMULATION PROCEDURE, HIGH IMPEDANCES WERE IDENTIFIED WITH THE EXTENSION, AS EVERY SEGMENT/CONTACT MEASURED OVER 5K OHMS. AFTER WIPING DOWN THE EXTENSION AND RECONNECTING AT BOTH CONNECTION SITES, ALL BUT SEGMENT 10A CONTINUED TO SHOW IMPEDANCES OVER 5K OHMS. SWITCHING PORTS AT THE BATTERY SITE DID NOT RESOLVE THE ISSUE, AS THE EXTENSION STILL EXHIBITED HIGH IMPEDANCES. A DIFFERENT EXTENSION WAS USED, AND ALL VALUES WERE CONFIRMED TO BE WITHIN NORMAL LIMITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415729 ↗
• MalfunctionDec 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH ELECTRIC RESISTANCE WAS IDENTIFIED WITH THE EXTENSION PRODUCT PRIOR TO IMPLANTATION. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE ISSUE RESOLVED WITH A REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866245 ↗
• InjuryDec 15, 2025Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE INDICATING THAT THE CAUSE OF THE CONNECTOR PLUG BECOMING LODGED IN THE EXTENSION WAS NOT DETERMINED; DURING THE STAGE 2 PROCEDURE THE TOP PORTION OF THE PLUG DETACHED FROM THE EXTENSION HEADER, LEAVING A FRAGMENT INSIDE, AND WHEN THE SCREW SET WAS LOOSENED THAT FRAGMENT FELL INTO THE EXTENSION BLOCK AND COULD NOT BE REMOVED; THIS HAS BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN. WHEN ASKING FOR CLARIFICATION OF PROCEDURES, THE REP STATED THAT THE PATIENT WAS HAVING THE STAGE 2 EXTENSION PLACEMENT AFTER HAVING 2ND SIDE LEAD IMPLANTATION AS THIS IS THE SURGEON'S PREFERENCE FOR HOW HE PERFORMS DEEP BRAIN STIMULATION PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804136 ↗
• InjuryOct 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT A PATIENT WITH DEEP BRAIN STIMULATION THERAPY EXPERIENCED A SUDDEN RETURN OF TREMOR. OUT OF RANGE (HIGH) IMPEDANCE WAS DETECTED AT CONTACT 1B, WHICH WAS A THERAPEUTIC CONTACT, AND THE IMPEDANCE ISSUE WAS ISOLATED TO THE LEFT EXTENSION. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THERAPY COULD NOT BE OPTIMIZED DESPITE REPROGRAMMING CONTACT 1B. BOTH EXTENSIONS WERE REPLACED AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shaking/Tremors

  MAUDE report 23427112 ↗
• MalfunctionOct 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE WAS DETECTED DURING INTRAOPERATIVE TESTING OF THE EXTENSION SEGMENT. MULTIPLE IMPEDANCE TESTS WERE CONDUCTED AT DIFFERENT LEVELS AND AMPLITUDES, AND A LEAD TEST WIRE WAS USED TO ASSESS WHETHER THE BRAIN LEADS WERE CAUSING THE HIGH IMPEDANCE. THE EXTENSION WAS NEVER IMPLANTED DUE TO UNRESOLVED HIGH IMPEDANCE. ALL MEASURES TO ADDRESS THE HIGH IMPEDANCE, INCLUDING WIPING BOTH ENDS OF THE EXTENSION AND LEADS MULTIPLE TIMES AND SUCTIONING THE BATTERY PORT AND EXTENSION/LEAD CONNECTION, WERE UNSUCCESSFUL. THE EXTENSION WAS SENT BACK TO THE MANUFACTURER FOR ASSESSMENT. A REPLACEMENT EXTENSION WAS OPENED AND IMPLANTED DURING THE SAME PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359919 ↗
• MalfunctionAug 7, 2025High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED THAT DURING THE CONNECTION OF THE RIGHT LEAD AND EXTENSION TO THE IMPLANTED NEUROSTIMULATOR, IMPEDANCE TESTING SHOWED ELEVATED VALUES ON ONE CONTACT. THE SURGEON NOTED DIFFICULTY SEATING THE ELECTRODE INTO THE EXTENSION AND TESTED THE BRAIN LEAD SEPARATELY, WHICH SHOWED NORMAL IMPEDANCES. THE EXTENSION WAS REPLACED, AND SUBSEQUENT IMPEDANCE TESTING SHOWED ALL VALUES WITHIN THE NORMAL RANGE. THE ISSUE WAS RESOLVED, AND NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL. THE PATIENT'S DEVICE WAS INTERROGATED POST-IMPLANT, AND IMPEDANCES REMAINED NORMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744765 ↗
• InjuryDec 2, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE, THE RIGHT EXTENSION WAS FOUND TO BE BENT AT THE CONNECTION SITE FOR THE BATTERY, AND UPON HANDLING, THE TIP OF THE EXTENSION FELL OFF. NO EXTERNAL FACTORS CONTRIBUTED TO THE ISSUE AND THERE WAS NO IMPEDANCE ISSUES. A NEW EXTENSION WAS RE-TUNNELED AND THE BROKEN PIECES WERE RETRIEVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20824625 ↗
• MalfunctionMar 19, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE NEURO EXTENSION WAS OPENED BUT NOT USED. IT GOT CONTAMINATED AND WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. THEY SHARED THAT THEY HAD A BACKUP EXTENSION THAT WE WERE ABLE TO USE AFTER IT WAS DROPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935762 ↗
• MalfunctionNov 22, 2023Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT THE BOX CONTAINING A LEAD AND EXTENSION THAT THE MANUFACTURER SENT FOR TRUNK STOCK PURPOSES WAS CRUSHED. WHEN OPENING THE BOX, THE ITEMS INSIDE WERE ALSO CRUSHED AND DAMAGED. THERE IS NO PATIENT, PHYSICIAN, OR FACILITY INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196685 ↗
• MalfunctionNov 10, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) WAS PRESENT FOR A STAGE 2 PLACEMENT. WHEN THEY ATTEMPTED TO CONNECT THE LEAD TO THE EXTENSION THE LEAD WOULD NOT FULLY ADVANCE INTO THE EXTENSION. THEY REMOVED THE SETSCREW, CLEAN THE LEAD, TRIED TO PUSH THE LEAD INTO THE EXTENSION, BUT THE ISSUE WAS NOT RESOLVED, THE CALLER INDICATED THAT THE CONNECTION WAS 2-3MM SHY OF THE GRAY RING ON THE LEAD. THE SURGEON USED A SECOND EXTENSION CONNECTED TO THE LEAD WITHOUT ISSUE. THE CALLER PLANS TO RETURN THE EXTENSION FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18111978 ↗
• MalfunctionNov 17, 2022High impedance; High impedance

  IT WAS REPORTED THAT THERE WERE OPEN CIRCUITS WHILE TESTING FINAL IMPEDANCES AFTER IMPLANT THAT WERE TRACED BACK TO THIS EXTENSION. LEAD TESTING AND IMPLANTABLE PULSE GENERATOR (IPG) TESTING SHOWED THE LEAD AND IPG WERE FINE. EXTENSION WAS SWAPPED WITH A NEW ONE AFTER IMPEDANCES WERE HIGH AND THE ISSUE WAS RESOLVED. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815144 ↗
• InjuryNov 12, 2022High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED THAT DURING INITIAL IMPLANT, WHEN ATTEMPTING TO CONNECT THE EXTENSION TO THE LEAD, THE EXTENSION DID NOT APPEAR TO ALLOW THE LEAD TO FULLY INSERT TO THE INDICATOR LINE. WHEN CHECKING IMPEDANCES, ALL CONTACTS WERE OUT OF NORMAL RANGE (OPEN CIRCUITS). AFTER SEVERAL ATTEMPTS TO FULLY SEAT THE LEAD, THE EXTENSION WAS REPLACED AND THE LEAD EASILY SEATED TO THE NEW EXTENSION, RESULTING IN NORMAL IMPEDANCE MEASUREMENTS. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS WERE IDENTIFIED THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785565 ↗
• MalfunctionOct 2, 2022Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE SCRUB NURSE WAS USED TO USING BOSTON SCIENTIFIC EXTENSIONS WHERE THEY BACK THE SCREW OUR BEFORE INSERTION OF THE DBS LEAD. UNFORTUNATELY THE NURSE ALSO BACKED THE SCREWS OUT FOR OUR EXTENSIONS, ENOUGH SO THEY JUST STAYED IN PLACE UNTIL THEY WERE PULLED THROUGH THE NECK WHERE THEY BECAME DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526413 ↗
• MalfunctionFeb 28, 2022Break; High impedance; Break; High impedance

  IT WAS REPORTED THAT CALLER WAS AT STAGE 2 IMPLANT TODAY, AND PHYSICIAN IMPLANTED EXTENSION. PATIENT HAD HIGH IMPEDANCE, PHYSICIAN THEN EXPLANTED THE EXTENSION, AND NOTICED THE EXTENSION HAD BROKEN OFF AT CONTACT 2 OF THE LEAD. CALLER REPORTS PHYSICIAN REPLACED WITH ANOTHER EXTENSION FROM HIS TRUNK STOCK. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620177 ↗
• MalfunctionJan 21, 2022Break; High impedance; Break; High impedance

  IT WAS REPORTED THAT THE EXTENSION WAS IMPLANTED AND WHEN IMPEDANCES WERE CHECKED CONTACT 0 AND 3 HAD OPEN CIRCUITS. IT WAS BROKEN. EXTERNAL FACTORS THAT MAY HAVE LED TO THE ISSUES IS THAT THE SURGEON HAD PULLED THE EXTENSION RATHER FORCEFULLY. IT WAS REPLACED AND ISSUE WAS RESOLVED AND DEVICE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314751 ↗

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-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-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-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.