SenSight™ B3300533MRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000426385), received between Oct 11, 2021 and Sep 29, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931877 ↗
• MalfunctionMar 17, 2026High impedance

  IT WAS REPORTED THAT PRIOR TO USE OF THE LEAD, INCREASED IMPEDANCE OF THE ELECTRODE WAS OBSERVED AND COULD NOT BE IMPROVED DESPITE MULTIPLE MEASUREMENTS, CONNECTING AND DISCONNECTING CABLES, AND MONOPOLAR MEASUREMENT. THE DEVICE WAS NEVER IMPLANTED. THE ISSUE WAS RESOLVED BY EXCHANGING THE DEVICE FOR 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 24621999 ↗
• MalfunctionNov 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE LEAD WAS BENT WHEN INSPECTED UPON OPENING. A DIFFERENT LEAD WAS USED AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23468035 ↗
• MalfunctionMay 27, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEAD END CAP WAS NOT INCLUDED IN THE PACKAGING. THEY OPENED A NEW LEAD PACKAGE BUT THE RESOLUTION WAS UNKNOWN. THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089504 ↗
• MalfunctionNov 22, 2024Device Damaged Prior to Receipt by User; Packaging Problem; Device Damaged Prior to Receipt by User; Packaging Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LEAD WAS STUCK IN THE PLASTIC PACKAGING AND PUNCTURED IT. THERE WERE NO CONTRIBUTING FACTORS. THE LEAD WAS NEVER IMPLANTED AND REPLACED WITH ANOTHER LEAD. THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20757834 ↗
• MalfunctionNov 5, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT WHEN TRYING TO REMOVE THE LEAD FROM THE PROTECTOR TO USE THE LEAD FOR IMPLANT, THE LEAD TIP WAS CAUGHT IN THE TIP OF THE PROTECTOR. NO FACTORS NOTED THAT LED TO THE ISSUE. THEY TRIED TO REMOVE THE LEAD FROM THE PROTECTOR UNSUCCESSFULLY. ANOTHER LEAD WAS USED FOR THE SURGERY. AFTER PROVIDING THE OTHER LEAD, THE FIELD AGENT TRIED HARDER TO REMOVE IT FROM THE PROTECTOR (HE COULD DO IT BY APPLYING A HIGHER FORCE AND FORGETTING ABOUT THE STERILIZATION PIECE). NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615357 ↗
• MalfunctionSep 3, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE LEAD HAD A PACKAGING ISSUE. THE PROTECTION CAP WAS PERFORATED BY THE LEAD AND THERE WAS NO KNOWN CAUSE FOR THE ISSUE. ANOTHER LEAD WAS USED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126637 ↗
• MalfunctionNov 28, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING STAGE 2 SURGERY, CONTACT 8 ON IMPLANTED LEAD SHOWED ELEVATED IMPEDANCE. MULTIPLE ATTEMPTS WERE MADE TO DISCONNECT, CLEAN, DRY, AND RE-INSERT THE LEAD. CONTACT 8 IMPEDANCE RESOLVED, AND CONTACT 11 SHOWED ELEVATED IMPEDANCE. A LEAD TEST CABLE WAS USED TO CHECK THE LEAD AND CONTACT 11 INDEPENDENTLY, AND HIGH IMPEDANCE PERSISTED. TO RESOLVE THE ISSUE, THE LEAD WAS REPLACED WITH A NEW LEAD WITH NO PROBLEM. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. THE LEAD WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223500 ↗
• MalfunctionNov 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE TRANSPORT-CANNULA OF THE SENSIGHT ELECTRODE HAD A HOLE ON ONE SIDE AND THE ELECTRODE TIP GOT CAUGHT IN IT. THEY COULDN'T REMOVE IT FROM THE SLEEVE. THEY LIGHTLY TAPPED THE TRANSPORT CANNULA SEVERAL TIMES SO THAT THE ELECTRODE WAS RELEASED AND COULD BE REMOVED. THE ISSUE HOWEVER WAS SAID TO NOT BE RESOLVED. THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212197 ↗
• MalfunctionOct 2, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE ELECTRODE PACKAGING WAS OPENED DURING SURGERY. WHEN THE ELECTRODE WAS REMOVED FORM THE PACKAGING THE END OF THE ELECTRODE WAS BENT. THE ELECTRODE WAS PUT ASIDE AND A NEW ELECTRODE WAS OPENED AND IMPLANTED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17853164 ↗
• MalfunctionApr 10, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO PULL THE LEAD OUT OF THE PACKAGING TUBE, SO ANOTHER LEAD WAS IMPLANTED. THE ISSUE WAS RESOLVED. THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709932 ↗
• MalfunctionMay 20, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEAD CAP WAS MISSING IN THE BOX. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE LEAD WAS CHANGED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14455347 ↗
• MalfunctionMay 4, 2022Difficult to Remove; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A PROBLEM DURING THE IMPLANT PROCESS. AFTER REMOVAL OF THE BLUE CAP CLOSURE, THE SENSIGHT LEAD COULD NO LONGER SLIP OUT OF THE SLEEVE WITHOUT PROBLEMS. THERE WERE NO EXTERNAL FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE AND NO VISIBLE DAMAGE OR KINKS. THE NEUROSURGEON WAS CONCERNED WHETHER THE LEAD WAS STILL INTACT. THEREFORE, A NEW SENSIGHT LEAD WAS IMPLANTED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272621 ↗
• InjuryOct 11, 2021Unstable; Material Deformation; Unstable; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE BURR HOLE THAT IS STILL IN USE, BUT WHEN ASKED TO CLARIFY IT WAS STATED THAT THE BURR HOLE WAS WORKING CORRECTLY. THE CAUSE OF THE LEAD BEING UNTHREAD FROM ITS POSITION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606331 ↗

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.