SenSight™ B3300533Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000426378), received between Dec 29, 2021 and May 7, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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.

• MalfunctionMay 7, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION IMPLANTATION PROCEDURE, THE LEAD WAS REMOVED FROM THE PACKAGING AND PLACED ON A RULER TO MEASURE IMPLANTATION DEPTH WHEN THE PHYSICIAN OBSERVED THAT THE LEAD TIP WAS CROOKED. THE PHYSICIAN ROTATED THE LEAD TO VERIFY ALIGNMENT AND NOTED THAT THE LEAD WAS NOT STRAIGHT, AND EXPRESSED CONCERN THAT USE OF THE CROOKED LEAD COULD MISS THE INTENDED DEEP BRAIN STIMULATION TARGET. THE LEAD WAS REPLACED WITH ANOTHER ONE 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 25116821 ↗
• MalfunctionFeb 5, 2026High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE GREATER THAN 5K OHMS WAS DETECTED ON SEGMENT 2B OF A LEAD DURING DEEP BRAIN STIMULATION. NO SYMPTOMS, COMPLICATIONS, ADVERSE EVENTS, OR SURGICAL INTERVENTIONS WERE REPORTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272683 ↗
• MalfunctionJan 23, 2026Material Deformation

  IT WAS REPORTED THAT THE LEAD WAS FOUND TO BE BENT WHEN REMOVED FROM THE PACKAGE PRIOR TO USE IN SURGERY. THE LEAD WAS NOT USED, AND ANOTHER LEAD WAS SELECTED FOR THE PROCEDURE. THE ISSUE WAS RESOLVED BY USING A REPLACEMENT LEAD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168059 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. THE CAUSE OF THE SCALP ISSUE WAS DUE TO PATIENT SCRATCHING FOR NO KNOWN REASON.

  Patient problems: Insufficient Information; Itching Sensation

  MAUDE report 21866650 ↗
• MalfunctionMar 17, 2025Packaging Problem; Insufficient Device Problem Information; Packaging Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE ELECTRODE WAS ALLEGED TO BE STUCK IN THE SLEEVE AND COULD NOT BE REMOVED FROM THE PACKAGING IN THE FIRST PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618743 ↗
• MalfunctionJan 21, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE DEVICE WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201278 ↗
• MalfunctionJan 16, 2025Device 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 21173534 ↗
• MalfunctionDec 10, 2024Material Twisted/Bent; Packaging Problem; Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT WHEN THE LEAD WAS TAKEN OUT FROM THE PACKAGE, THE LEAD WAS STUCK IN ITS PROTECTIVE COVER AND APPEARED BENT AT THE TIP. NO EXTERNAL FACTORS OR VISIBLE DAMAGES WERE NOTED. WHEN ATTEMPTING TO SHAKE THE COVER A LITTLE BIT, NOTHING CHANGED, ONLY THE MANDRIN CAME OUT OF THE LEAD. THE ISSUE WAS RESOLVED BY EXCHANGING THE LEAD WITH ANOTHER PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892513 ↗
• MalfunctionNov 21, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE INVOLVING THE LEAD DEVICE, THE ELECTRODE COULD NOT BE REMOVED FROM ITS COVERING. DESPITE ATTEMPTS TO SHAKE IT SEVERAL TIMES, THE ISSUE PERSISTED. NO SURGICAL INTERVENTION OCCURRED, NOR WAS ANY PLANNED. THE DEVICE WAS NEVER IMPLANTED, AND THE ISSUE REMAINED UNRESOLVED AT THE TIME OF THE REPORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749273 ↗
• MalfunctionJun 24, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE LEAD PACKAGING WAS DAMAGED INSIDE THE BOX. NO SYMPTOMS REPORTED. THE DEVICE WAS NEVER IMPLANTED. NO EXTERNAL FACTORS LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS REPORTED TO BE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595400 ↗
• MalfunctionJan 20, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE LEAD KIT WAS MISSING A CAP. THE SURGEON SORTED IT OUT AND FOUND ANOTHER SOLUTION. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214719 ↗
• MalfunctionJul 12, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN OPENING THE BOX OF THE LEAD IT WAS NOTICED THAT ONE OF THE ENDS/TIP WAS BENT. THE PRODUCT WOULD NOT BE IMPLANTED AND ANOTHER LEAD WOULD BE USED. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987559 ↗
• MalfunctionFeb 4, 2022High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT WHILE INSERTING THE LEAD IMPEDANCE MEASUREMENTS WERE DONE USING A LEAD TEST CABLE. BIPOLAR IMPEDANCE MEASUREMENTS WERE OK, UNIPOLAR MEASUREMENTS WERE INCONCLUSIVE (SOMETIMES VERIFICATION FAILED, SOMETIMES IMPEDANCES WERE LARGER THAN 10K OHMS, SOMETIMES OK). THE LEAD WAS REPLACED BY ANOTHER ONE AND THE LEAD TEST CABLE WAS DISCARDED. THERE WERE NO PHYSICIAN PROGRAMMER REPORTS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453264 ↗
• MalfunctionDec 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN THE NEW LEAD WAS TAKEN OUT OF THE BOX IT WAS BENT. THERE WAS NO DIFFICULTY TAKING IT FROM THE STRAW, AND THE STRAW DIDN'T SHOW ANY DEFORMATION. NO BIND WAS DUE TO MISHANDLING OF THE LEAD. A NEW LEAD WAS USED AND THE IMPLANTING PROCEDURE CONTINUED AS INTENDED. THERE WERE NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13111359 ↗

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.