SenSight™ B3301542MRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00763000426446), received between Jun 28, 2021 and Sep 29, 2026 — classified as 3 deaths, 17 injuries, 23 malfunctions.

The most frequently reported specific device problem is “High impedance” (13 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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Impedance Problem

  It was reported that impedances were out of range when tested in the operating room, with red contacts noted on contacts 2c and 3 after the lead was placed. The HCP and manufacturer representative attempted multiple troubleshooting steps, including removing and wiping down the lead, but the impedances did not clear. The lead was removed and replaced with a second lead, which showed good impedances. The issue was resolved following surgical intervention, and no further information was available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927276 ↗
• MalfunctionSep 25, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892673 ↗
• MalfunctionMar 16, 2026High impedance

  IT WAS REPORTED THAT THEY HAD ISSUES WITH A LEAD INTRA-OP WITH HIGH IMPEDANCES. CALLER STATED THAT HIGH IMPEDANCES WEREN'T CONSISTENT AND ALTERNATING CONTACTS. CALLER STATED THE LEAD WAS DISCARDED AND ANOTHER LEAD WAS USED WITHOUT ISSUE. CALLER ALSO HAD 2 BURR HOLE DEVICES THAT WERE OPENED BUT NOT USED. TROUBLESHOOTING WAS NOT REQUIRED. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. TECHNICAL SERVICES TRANSFERRED CALLER TO CUSTOMER SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24609155 ↗
• InjuryFeb 13, 2026High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT LEAD WAS PLACED INTO CANNULA, LEAD TEST CABLE WAS ATTACHED, AND WE CONNECTED TO LEAD WITH TABLET. HCP WENT TO SETUP THE TABLET TO PERFORM CONNECTIVITY AND IMPEDANCE CHECK IN ORDER TO DO INTRAOPERATIVE TESTING, AND ON CONTACT 2 (MONOPOLAR) AND CONTACT 2B THERE WAS IMPEDANCE ISSUES ABOVE 21K AND THE CONNECTIVITY TEST FAILED. NEUROSURGEON TOOK LEAD TEST CABLE OFF DISTAL PORTION OF LEAD, RECONNECTED AND TURNED THE CABLE BOX 90 DEGREES LEFT AND RIGHT. HE ENSURED THE STYLET WAS PUSHED ALL THE WAY DOWN BEFORE PLACING IT INTO THE MEASURING TOOL. ANOTHER LEAD TEST CABLE KIT WAS OPENED, AND THE SAME ISSUE OCCURRED WITH BOTH THE IMPEDANCE CHECK OUT OF RANGE AND CONNECTIVITY TEST FAILING. WE THEN OPENED A NEW 1.5MM LEAD, RECONNECTED WITH LEAD TEST CABLE AND THE CONNECTIVITY TEST PASSED AND IMPEDANCE CHECK CAME BACK ALL WITHIN NORMAL RANGES. ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT CAUSE OF THE IMPEDANCE REMAINS UNKNOWN. THEY ELABORATE THAT THE LEAD WITH HIGH IMPEDANCE WAS REPLACED AND WAS RETURNED FOR ANALYSIS. REP EXPLAINS THAT TO TROUBLESHOOT THEY RE-RAN IMPEDANCE AND CONNECTIVITY TEST AGAIN WITH THE LEAD, BUT WHEN IT CONTINUED TO FAIL, THEY FIRST OPENED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24334534 ↗
• MalfunctionFeb 5, 2026Migration or Expulsion of Device; Difficult to Remove; Malposition of Device

  IT WAS REPORTED THAT SURGEON PROVIDED FEEDBACK WHEN PULLING STYLET OUT FROM 1.5MM LEAD BEFORE FIXATING IT TO BHD AND SKULL THAT HE FELT THAT THE STYLET WAS DIFFICULT TO REMOVE FROM THE LEAD; THAT IT FELT TIGHT WITHIN THE LEAD AND CAUSED THE LEAD TO MOVE UPWARDS AND CAUSE ORIGINAL PLACEMENT CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268321 ↗
• MalfunctionOct 15, 2025High impedance; Material Deformation; High impedance; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED FROM REP INDICATING THAT ROOT CAUSE OF THE IMPEDANCE WAS EITHER USE ERROR AS THE SURGEON DISCOVERED A KINK AT THE DISTAL END OF THE LEAD THAT RESOLVED THE IMPEDANCE AFTER BEING STRAIGHTENED OUT OR ANATOMICAL FACTORS AS IMPEDANCE RESOLVED AFTER RUNNING A HIGHER LEVEL OF CURRENT, 1.5MA, THROUGH THE CONTACT. THEY RECOUNT THE FULL CONTEXT AS THEY WERE PERFORMED A STAGE 2 CONNECTION SURGERY, TEXTED IMPEDANCES AT 1.0 MA WHEN THE SYSTEM WAS CONNECTED AND THE BATTERY WAS INSIDE THE CHEST POCKET, AND IT SHOWED AN OPEN CIRCUIT (HIGH IMPEDANCES) AT CONTACT 1A ACROSS ALL CONTACTS IN BIPOLAR AND MONOPOLAR. THEY OPENED AN EXTENSION TEST CABLE AND THE PROBLEM PERSISTED, MEANING THE BATTERY WAS NOT THE ISSUE. THEY THEN OPENED A LEAD TEST CABLE AND THE PROBLEM SOMEWHAT RESOLVED (AT FIRST SHOWED OPENS AT ONLY SOME CONTACTS IN BIPOLAR, AND THE RESOLVED COMPLETELY). THEY THEN OPENED ANOTHER EXTENSION WIRE, THINKING THAT WAS THE PROBLEM, CONNECTED IT TO THE LEAD AND BATTERY WITHOUT TUNNELING , AND THE PROBLEM OCCURRED AGAIN, OPEN AT ALL CONTACTS ACROSS 1A. THIS LED THEM TO BELIEVE THAT THE ORIGINAL EXTENSION WIRE WAS NOT THE ISSUE, SO THEN THEY SENT 1.5MA OF CURRENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299909 ↗
• InjuryJun 27, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT IMPEDANCE ISSUES OCCURRED WITH THE LEAD DURING A PROCEDURE TO PLACE A DEEP BRAIN STIMULATION DEVICE. TROUBLESHOOTING INCLUDED TESTING USING A NEW TEST CABLE. THE ISSUE WAS RESOLVED BY REPLACING THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) DURING FOLLOW-UP. THE CAUSE OF IMPEDANCE ISSUES WAS NOT DETERMINED. THERAPEUTIC CONTACTS WERE NOT AFFECTED SO NO ACTION HAS BEEN TAKEN OR WAS PLANNED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350772 ↗
• MalfunctionMay 22, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS TO REPORT THE EVENT. THE CALLER INDICATED THAT THEY HAD A CASE TODAY FOR A LEAD IMPLANT. DURING THE CASE THE SURGEON BENT THE FIRST LEAD WHILE PREPPING THE COMPONENT.  WITH THE SECOND LEAD AFTER IT WAS PLACED, THEY RAN AN IMPEDANCE TEST WITH THE TEST CABLE AND HAD A VALUE ON ONE SEGMENT THAT WAS A LITTLE ABOVE 8000OHMS. THEY DISCONNECTED/RECONNECTED THE LEAD AND CONTINUED TO HAVE IMPEDANCES ISSUES A LITTLE ABOVE 8000OHMS. THEY CHANGED THE TEST CABLE AND CONTINUED TO HAVE ELEVATED IMPEDANCES SO THE LEAD WAS REPLACED. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22074634 ↗
• MalfunctionDec 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PROCEDURE, A LEAD WAS FOUND TO BE BENT JUST ABOVE THE MOST PROXIMAL CONTACT WHEN THE STYLET WAS SLIGHTLY BACKED OUT. THIS OBSERVATION WAS MADE WHILE THE LEAD WAS ON THE BACK TABLE IN THE OPERATING ROOM. THE SURGEON OPTED NOT TO IMPLANT THIS LEAD DUE TO THE BEND AND INSTEAD USED A SECOND LEAD OF THE SAME MODEL. THERE WERE NO ENVIRONMENTAL OR EXTERNAL FACTORS CONTRIBUTING TO THE ISSUE. THE PROBLEM WAS RESOLVED WITH THE SUCCESSFUL IMPLANTATION OF THE SECOND LEAD. NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898991 ↗
• MalfunctionOct 9, 2024High impedance; High impedance

  THE MANUFACTURER REPRESENTATIVE (REP) PROVIDED ADDITIONAL INFORMATION THAT THE IMPEDANCES CLEARED AT STAGE 2 OF THE SURGERY, RESOLVING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407570 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM THE HEALTHCARE PROVIDER (HCP) THAT PATIENT (PT) ONLY HAS A LEAD IMPLANTED, INQUIRING IF PT CAN HAVE MRI. CALLER STATED THEY HAD TO ABORT THE PROCEDURE ON (B)(6) 2023 DUE TO PT'S CONDITION, PT WAS HAVING STROKE-LIKE SYMPTOMS. CALLER BELIEVES LEAD WAS CAPPED.

  Patient problems: Dysphasia; Stroke/CVA

  MAUDE report 19011580 ↗
• MalfunctionFeb 7, 2024Connection Problem; Impedance Problem; Connection Problem; Impedance Problem

  IT WAS REPORTED THAT WHEN CONNECTING THE LEAD TEST CABLE TO THE SENSIGHT LEAD, AND PERFORMING THE CONNECTIVITY TEST THE TEST WOULD NOT VERIFY. THE MANUFACTURER REPRESENTATIVE (REP) ENSURED THAT THE STYLET IN THE LEAD WAS PUSHED DOWN BEFORE PLACING THE LEAD IN THE MEASURING TOOL, AND THE SURGICAL TEAM VERIFIED THEY DID. REP ALSO CONFIRMED THEY TURNED THE LEAD TEST CABLE ON THE LEAD 90 DEGREES CLOCKWISE AND COUNTERCLOCKWISE AND THEY DID. IT WAS MADE SURE TO WIPE DOWN THE LEAD BEFORE PLACING THE LEAD TEST CABLE ON THE LEAD, AND THE CONNECTIVITY TEST WOULD NOT VERIFY. REP TRIED THESE STEPS ONCE MORE AND THE CONNECTIVITY TEST WOULD NOT VERIFY. A NEW LEAD TEST CABLE WAS OPENED, HOWEVER, THE CONNECTIVITY TEST WOULD STILL NOT VERIFY. THE TROUBLESHOOTING EVENTS WERE REPEATED, AND NOTHING CHANGED. A NEW SENSIGHT LEAD WAS OPENED AND USED THE LEAD TEST CABLE, RAN THE CONNECTIVITY TEST AND IT VERIFIED AFTER THE NEW LEAD WAS OPENED AND IMPLANTED. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE LEAD CONNECTIVITY ISSUE WASN¿T DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18663910 ↗
• MalfunctionJan 4, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT LEAD IMPEDANCE ISSUES DURING MONOPOLAR INTRA-OP TESTING. ALL MONOPOLAR CONTACTS WERE SHORT, ALL BIPOLAR CONTACTS WERE WITHIN RANGE. SINCE IT WAS ONLY THE MONOPOLAR CONTACTS, IT WAS ASSUMED IT'S A GROUNDING ISSUE AS THE BIPOLAR CONTACTS WERE ALL CLEAR. DIFFERENT GROUNDING DIDN'T RESOLVE, STYLET WAS RAISED, TRIED DIFFERENT TESTING CABLE, TRIED DIFFERENT ENS, RESTARTED TABLET, ONLY NEW LEAD RESOLVED THE ISSUE. NEW LEAD WAS USED AND ADVISED NEUROSURGEON TO PUSH STYLET DOWN BEFORE SECURING. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443501 ↗
• MalfunctionDec 1, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, WHEN OPENING THE 1.5MM SENSIGHT LEAD, THE INTEGRITY OF THE INTERNAL PACKING WAS COMPROMISED. THEN ANOTHER1.5MM SENSIGHT LEAD WAS GOING TO BE OPENED AND THAT INTERNAL PACKAGING WAS ALSO COMPROMISED. AFTER GETTING A THIRD LEAD TO OPEN, IT WAS THEN IN-TACT AND THE MANUFACTURER REPRESENTATIVE (REP) COULD HAVE IT OPENED TO BE IMPLANTED. THE MANUFACTURER REPRESENTATIVE (REP) CLARIFIED THAT THE ISSUE WITH THE PACKAGING WAS A STERILE SEAL ISSUE. SEE RELATED REPORT NUMBER 2649622-2023-34219.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247875 ↗
• MalfunctionDec 1, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, WHEN OPENING THE 1.5MM SENSIGHT LEAD, THE INTEGRITY OF THE INTERNAL PACKING WAS COMPROMISED. THEN ANOTHER 1.5MM SENSIGHT LEAD WAS GOING TO BE OPENED AND THAT INTERNAL PACKAGING WAS ALSO COMPROMISED. AFTER GETTING A THIRD LEAD TO OPEN, IT WAS THEN IN-TACT AND THE MANUFACTURER REPRESENTATIVE (REP) COULD HAVE IT OPENED TO BE IMPLANTED. THE MANUFACTURER REPRESENTATIVE (REP) CLARIFIED THAT THE ISSUE WITH THE PACKAGING WAS A STERILE SEAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247782 ↗
• MalfunctionNov 20, 2023High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) THE CAUSE OF THE IMPEDANCE ISSUE WASN¿T DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18167536 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT (PT) EXPERIENCED SEIZURES INTRAPERSONAL AND POST-OP. POST-OP IMAGING WAS DONE. THE ISSUE WAS RESOLVED.

  Patient problems: Convulsion/Seizure

  MAUDE report 18140108 ↗
• InjuryOct 9, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD HAD IMPEDANCE ISSUES AFTER TAKING INNER STYLET OUT AND PUT BACK IN. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS PLACED. NO ISSUES WITH NEW LEAD. AT INITIAL IMPLANTATION, IMPEDANCES WERE OK. AFTER THE INNER STYLER WAS TAKEN OUT AND PUT BACK IN, IMPEDANCES WERE ¿HIGH¿ AT CONTACT 2. TROUBLESHOOTING WAS DONE, HEALTHCARE PROVIDER (HCP) TRIED RECONNECTING THE LEAD TEST CABLE. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896551 ↗
• MalfunctionSep 21, 2023Break; Device Damaged Prior to Receipt by User; Break; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) RECEIVED A B3301542M AND THE EXTERNAL BOX WAS CRUSHED AND WHEN OPENING THE BOX, THE ITEM WAS ALSO CRUSHED AND DAMAGED. THE TRACKING NUMBER ON THE FEDEX BOX IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788750 ↗
• MalfunctionAug 30, 2023High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER LEAD WAS IMPLANTED FOR INTRA-OPERATIVE STIMULATION TESTING, IMPEDANCES WERE CHECKED AND AFTER SEVERAL ATTEMPTS, WE COULD NOT CLEAR CONTACT 2 HAVING A POSSIBLE OPEN CIRCUIT. LEAD WAS WIPED DOWN BEFORE PLACING IN THE MEASURING TOOL, AND THE LEAD TEST CABLE WAS TURNED 90 DEGREES RIGHT AND LEFT WHEN IT WAS ATTACHED TO THE DISTAL END OF THE LEAD PRIOR TO CONNECTING. WHEN IMPEDANCES DID NOT CLEAR, A NEW LEAD WAS OPENED AND USED AS THE ORIGINAL LEAD WAS MALFUNCTIONING INTRA-OPERATIVELY. WHEN IMPEDANCES WERE RUN ON SECOND LEAD, THERE WERE NO ISSUES THE ISSUE WAS NOT RESOLVED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE HIGH IMPEDANCE WASN¿T DETERMINED AND DIDN¿T RESOLVE INITIALLY. TO RESOLVE THE ISSUE A NEW LEAD WAS OPENED, AND IMPEDANCES WERE FINE UPON IMPEDANCE CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17648936 ↗
• MalfunctionAug 7, 2023High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT IMPEDANCES WERE ALL OUT OF RANGE WHEN CHECKED DURING A STAGE 1 CASE. THE FIRST HEMISPHERE WAS FINE, BUT WHEN THE SECOND LEAD WAS CHECKED WITH THE SAME TEST CABLE, ALL OF THE IMPEDANCES WERE OUT OF RANGE. IT WAS CHECKED IN BIPOLAR AND THEY ALL CAME UP AS SHORTS(RED). THE LEAD WAS TAKEN OUT OF THE TEST CABLE TWO DIFFERENT TIMES AND RECHECKED. A NEW LEAD WAS USED AND ALL OF THE IMPEDANCES WERE WITHIN RANGE AND GOOD. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470342 ↗
• InjuryJul 25, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING A STAGE 1 LEAD IMPLANT SURGERY, THE CONNECTIVITY TEST FAILED AND THE IMPEDANCE CHECK WAS OUT OF RANGE. ATTEMPTED THE CHECK SEVERAL TIMES, CHANGED OUT ENS, RESTARTED CLINICIAN TABLET, TESTED WITH 2 DIFFERENT LEAD TEST CABLES AND COULD NOT ACHIEVE AN IMPEDANCE CHECK WITHIN RANGE. SURGEON ASKED FOR A NEW LEAD AND ALL IMPEDANCES WERE WITHIN ACCEPTABLE RANGE RIGHT AWAY. 7 MINUTE DELAY OF CASE WITH NO HARM TO THE PATIENT. THE CASE PROCEEDED WITHOUT ISSUE FROM THAT POINT ON AND THE PATIENT HAD AN EXCELLENT RESPONSE TO INTER OP TRIALING. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393129 ↗
• MalfunctionJul 20, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STYLET WAS UNABLE TO BE REMOVED FROM THE LEAD. THE LEAD WAS REPLACED WITH A NEW LEAD. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362140 ↗
• MalfunctionFeb 28, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE LEAD WAS CAREFULLY TAKEN OUT OF THE STERILE PACKAGING UNDER THE MANUFACTURER REPRESENTATIVE'S (REP'S) SUPERVISION AND VERY CAREFULLY INSERTED AT THE PHANTOM OF THE RM FRAME. THERE, IT WAS VISIBLE THAT THE PROXIMAL END, APPROX. 2 CM, HAD A BEND. THERE WAS NO VISIBLE DEFECTS AND NO ABNORMALITIES IN THE PACKAGING. THE ELECTRODE WAS CAREFULLY PLACED BACK INTO THE PACKAGING. A NEW PACKAGING WAS OPENED AND THE NEW ELECTRODE WAS NORMAL. THE SURGERY HAD A DELAY DUE TO THIS.  THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457080 ↗
• InjuryFeb 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LEAD NEEDED TO BE EXPLANTED AND RE-IMPLANTED WITH A NEW LEAD DUE TO DEFLECTION OF THE LEAD AT ORIGINAL IMPLANTATION ((B)(6) 2022). NEUROSURGEON AND NEUROLOGIST STATED THAT WITH ORIGINAL IMPLANTED LEAD, PATIENT WAS RECEIVING NO THERAPY BENEFIT. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE KNOWN. THE PATIENT RECEIVED NECESSARY IMAGING TO SEE IF ORIGINAL LEAD WAS CORRECTLY PLACED AND IT WAS NOTICED THAT THERE WAS DEFLECTION. THE PATIENT CAME BACK TO SURGERY ON (B)(6) 2023 AND HAD ORIGINAL LEAD EXPLANTED, AND A NEW LEAD IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 16378823 ↗

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.