SenSight™ B3300542Recalls & reported problems

Summary

The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 00763000426392), received between Jun 8, 2021 and Jul 10, 2026 — classified as 3 deaths, 44 injuries, 83 malfunctions.

The most frequently reported specific device problem is “High impedance” (49 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 130 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25785410 ↗
• MalfunctionJun 1, 2026Difficult to Insert; Positioning Problem

  IT WAS REPORTED THAT PATIENT WAS HAVING ELECTRODE IMPLANTED FOR PARKINSON'S DISEASE. PRIOR TO INSERTION, HCP OBSERVED THAT THE GUIDE WIRE WAS NOT SEATED INSIDE THE ELECTRODE PROPERLY. HIS OBSERVATION IS THAT THE GUIDE WIRE INTHIS PARTICULAR ELECTRODE WAS NOT CUT TO SPECIFICATIONS AND IS PERHAPS LONGER THAN THE MANUFACTURED SPECIFICATIONS. HE DEEMED THIS A POSSIBLE QUALITY ISSUE AND DID NOT FEEL COMFORTABLE IMPLANTING THE ELECTRODE. HE ASKED FOR ANOTHER ELECTRODE AND WAS SATISFIED WITH HOW THE GUIDE WIRE WAS SEATED IN THE ELECTRODE AND THE 2ND ELECTRODE WAS IMPLANTED IN THE PATIENT. ISSUE IS REITERATED, REP SAID THE LEAD STYLET WOULD NOT SIT FLUSH, WHEN THE SURGEON PUSHED IT IN, IT WOULD POP OUT AGAIN. SURGEON THINKS THE STYLET MIGHT BE TOO LONG OR THERE MIGHT BE AN OBSTRUCTION IN THE LEAD LUMEN. REP TO SEND LEAD BACK FOR ANALYSIS. OUT-OF-BOX ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25348071 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CEREBRAL HEMORRHAGE OCCURRED POST-OPERATIVELY; THE DOCTOR HAS ALREADY ADDRESSED IT. THE ISSUE WAS RESOLVED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 25278565 ↗
• MalfunctionMay 19, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, AN INTRAOPERATIVE IMPEDANCE CHECK IDENTIFIED HIGH LEAD IMPEDANCE. THE LEAD WAS REPLACED WITH A NEW ONE ON THE SAME DAY, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE ISSUE WAS REPORTED AS RESOLVED, AND THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222285 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS EXPLANTED DUE TO SKIN EROSION AROUND THE BURR HOLE SITE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE REPORTED TO BE OBSERVED. A FUTURE REIMPLANTATION WAS PLANNED FOR A LATER DATE. THE ISSUE WAS RESOLVED AT TIME OF THIS REPORT.

  Patient problems: Skin Erosion

  MAUDE report 25202840 ↗
• 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 25073074 ↗
• MalfunctionApr 22, 2026Material Deformation

  IT WAS REPORTED THAT LEAD WAS OPENED AND WAS FOUND TO BE BENT. NEW LEAD OPENED AND USED INSTEAD. DEVICE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953469 ↗
• MalfunctionApr 16, 2026High impedance

  IT WAS REPORTED THAT THERE WERE EXCESSIVELY HIGH LEAD IMPEDANCES OBSERVED INTRAOPERATIVELY. THE LEAD WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899239 ↗
• MalfunctionApr 16, 2026High impedance

  IT WAS REPORTED THAT DURING A STAGE ONE PROCEDURE, INTRAOPERATIVE LEAD TESTING SHOWED ABNORMAL RESULTS WITH THE CONTACTS DISPLAYING ALL RED. THE LEAD WAS TESTED MULTIPLE TIMES AND CONTINUED TO SHOW ALL RED- HIGH IMPEDANCES - ON THE CONTACTS AFTER REINSERTION INTO THE BRAIN. A SECOND LEAD WAS THEN TESTED AND SHOWED THE SAME ALL RED RESULTS, AND A SECOND TESTING CABLE WAS ALSO TRIED WITH THE SAME FINDINGS. THE LEAD WAS REMOVED AND PLACED IN STERILE SALINE ON THE STERILE TABLE, WHERE TESTING SHOWED ALL GREEN - NORMAL IMPEDANCES- AND THE CANNULA WAS PULLED UP 24 MM IN THE BRAIN TO ENSURE IT WAS NOT NEAR THE ELECTRODES. DURING CONTINUED TESTING, THE CONTACTS REPORTEDLY BEGAN TO SHOW ¿GREEN.¿ NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. DURING FOLLOW UP FOR ADDITIONAL INFORMATION, THE MANUFACTURER REPRESENTATIVE (REP) REITERATED THAT TROUBLESHOOTING INCLUDED MOVING THE CANNULA, SWAPPING OUT THE LEAD AND TEST CABLE, TESTING THE LEAD THE SECOND LEAD IN A SALINE BATH. THEY RECONFIRMED THAT AFTER RUNNING THE IMPEDANCE CHECK A COUPLE TIMES, THE SECOND LEAD RECEIVED NORMAL IMPENDENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899046 ↗
• MalfunctionApr 16, 2026High impedance

  IT WAS REPORTED THAT DURING A STAGE ONE PROCEDURE, INTRAOPERATIVE LEAD TESTING SHOWED ABNORMAL RESULTS WITH THE CONTACTS DISPLAYING ALL RED. THE LEAD WAS TESTED MULTIPLE TIMES AND CONTINUED TO SHOW ALL RED- HIGH IMPEDANCES - ON THE CONTACTS AFTER REINSERTION INTO THE BRAIN. A SECOND LEAD WAS THEN TESTED AND SHOWED THE SAME ALL RED RESULTS, AND A SECOND TESTING CABLE WAS ALSO TRIED WITH THE SAME FINDINGS. THE LEAD WAS REMOVED AND PLACED IN STERILE SALINE ON THE STERILE TABLE, WHERE TESTING SHOWED ALL GREEN - NORMAL IMPEDANCES- AND THE CANNULA WAS PULLED UP 24 MM IN THE BRAIN TO ENSURE IT WAS NOT NEAR THE ELECTRODES. DURING CONTINUED TESTING, THE CONTACTS REPORTEDLY BEGAN TO SHOW ¿GREEN.¿ NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. DURING FOLLOW UP FOR ADDITIONAL INFORMATION, THE MANUFACTURER REPRESENTATIVE (REP) REITERATED THAT TROUBLESHOOTING INCLUDED MOVING THE CANNULA, SWAPPING OUT THE LEAD AND TEST CABLE, TESTING THE LEAD THE SECOND LEAD IN A SALINE BATH. THEY RECONFIRMED THAT AFTER RUNNING THE IMPEDANCE CHECK A COUPLE TIMES, THE SECOND LEAD RECEIVED NORMAL IMPENDENCE'S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898816 ↗
• MalfunctionApr 13, 2026Material Deformation

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, AN ELECTRODE ISSUE WAS IDENTIFIED INTRAOPERATIVELY WHEN THE LEAD WAS OBSERVED TO BE BENT. THE LEAD WAS REPLACED WITH A NEW LEAD ON THE SAME DAY TO COMPLETE THE PROCEDURE, AND THE ISSUE WAS REPORTED AS RESOLVED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860676 ↗
• MalfunctionApr 7, 2026High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE ON SEGMENT 2A (>10,000 OHMS) ON THE LEAD WAS NOTED PRIOR TO USE. A SECOND LEAD TEST CABLE WAS USED FOR TROUBLESHOOTING AND THE HIGH IMPEDANCE PERSISTED AND THUS LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800373 ↗
• MalfunctionMar 30, 2026High impedance

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION LEAD WAS IDENTIFIED WITH EXCESSIVELY HIGH LEAD IMPEDANCE IN THE CONTEXT OF A DEVICE THAT WAS NEVER IMPLANTED. THE EVENT WAS ASSOCIATED WITH A PATIENT, AND THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO SURGICAL INTERVENTION OCCURRED AND NONE WAS PLANNED. A GUARANTEE REPLACEMENT WAS PERFORMED, AND THE ISSUE WAS REPORTED AS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24735552 ↗
• MalfunctionMar 17, 2026Malposition of Device

  IT WAS REPORTED THAT THE DESIGN OF THE BURR HOLE CLIP IS NOT EASY TO SECURE. HE STRUGGLES WITH GETTING IT TO ENGAGE IN THE RING. BECAUSE OF THE DESIGN, THIS IS ADDING TO THE PROCEDURE'S OR TIME. HE AND HIS FELLOW/RESIDENTS STRUGGLE WITH IT. TODAY'S CASE IS AN EXAMPLE OF HOW THE LEAD ON THE LEFT WAS SLIGHTLY PULLED OUT WHEN THEY HAD TO STRUGGLE TO SECURE THE CLIP. THEY HAD TO OPEN THE CLIP, PUSH THE LEAD BACK IN, AND THEN DO A THIRD SCAN TO CONFIRM CORRECT PLACEMENT. AFTER THE THIRD CT SCAN, THE LEAD DID NOT MOVE TO THE INTENDED LOCATION. THE FINAL LEAD PLACEMENT WAS NOT IN THE DESIRED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618385 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT CAUSE OF INFECTION WAS NOT DETERMINED BUT PATIENT HAS NOTED HISTORY OF INFE CTIONS. ISSUE HAS BEEN RESOLVED, PATIENT MAY HAVE SYSTEM REIMPLANTED AFTER SIX MONTHS.

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 24617112 ↗
• MalfunctionMar 9, 2026Break; High impedance

  IT WAS REPORTED THAT LEAD IMPEDANCES SHOWED ALL RED UPON TESTING IN THE OPERATING ROOM. EXTENSIVE TROUBLESHOOTING OCCURRED INCLUDING TRYING ANOTHER SECOND LEAD TEST CABLE. THE CANNULA WAS LIFTED, LEAD WIPED DOWN, ALTERNATE LEAD TEST CABLE TRIED, AND A NEW LEAD WAS IMPLANTED AND SHOWED NO IMPEDANCE ISSUES. MANUFACTURER REPRESENTATIVE (REP) HAS POSSESSION OF THE BROKEN LEAD AND WILL RETURN FOR ANALYSIS. REP REPORTS THE ISSUE HAS BEEN RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551796 ↗
• MalfunctionFeb 18, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION IMPLANTATION PROCEDURE, THE LEAD EXPERIENCED A MALFUNCTION. SPECIFICALLY, INTRA OPERATIVE TESTING REVEALED THAT THE ELECTRIC RESISTANCE OF THE LEAD FAILED (HIGH IMPEDANCE). THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24383716 ↗
• DeathFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THE PATIENT WAS NOW DECEASED. THE CASE HAD GONE AS EXPECTED; NO DEVICE OR IMPLANT MALFUNCTION WAS NOTED. IN POST-OP SOME TIME AFTER SURGERY, THE PATIENT HAD A SEIZURE. CT SCAN WAS TAKEN AND NO ABNORMALITY WAS FOUND. WHEN THE PATIENT DID NOT IMPROVE, AN MRI WAS ORDERED A LITTLE LATER THAT AFTERNOON/EVENING. A HEMORRHAGE WAS IDENTIFIED; LOCATION WAS NOT PROVIDED. THE PATIENT NEVER REGAINED CONSCIOUSNESS. PER THE FAMILY AND PATIENT'S ADVANCED DIRECTIVE THAT CARE SHOULD BE WITHDRAWN IF PATIENT WAS NOT GOING TO BE AS HE WAS BEFORE THE PROCEDURE, CARE WAS WITHDRAWN AND THE PATIENT PASSED AWAY ON SUNDAY, (B)(6). THIS INFORMATION WAS CONFIRMED WITH THE MANAGING PHYSICIAN.

  Patient problems: Convulsion/Seizure; Hemorrhage/Blood Loss/Bleeding; Intracranial Hemorrhage; Loss of consciousness

  MAUDE report 24333632 ↗
• MalfunctionJan 27, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT SURGEON IMPLANTED THE LEFT SIDED LEAD. THEY RUN AN IMPEDANCE TEST AND FOUND IMPEDANCE ISSUES ON MULTIPLE CONTACTS. WE TRIED RE-SEATING THE TEST CABLE SEVERAL TIMES, LOOSENED THE SCREW HOLDING THE LEAD IN PLACE, AND REPLACED THE TEST CABLE AND STILL HAD IMPEDANCE ISSUES ON MULTIPLE CONTACTS. THE SURGEON TOOK THE LEAD OUT AND REPLACED IT WITH A NEW LEAD. THE IMPEDANCES CLEARED UP WITH THE NEW LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191547 ↗
• InjuryJan 23, 2026High impedance

  IT WAS REPORTED THAT A PATIENT WITH PARKINSON'S DISEASE UNDERWENT DEEP BRAIN STIMULATION. THE LEAD EXPERIENCED A MALFUNCTION, INCLUDING ELECTRIC RESISTANCE THAT WAS TOO HIGH. AS A RESULT, THE PRODUCT WAS EXPLANTED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164918 ↗
• 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 (B)(6) 2026 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 24133362 ↗
• MalfunctionJan 12, 2026High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, HIGH LEAD ELECTRIC IMPEDANCE WAS DETECTED. A NEW LEAD WAS IMPLANTED ON THE SAME DAY TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044980 ↗
• MalfunctionJan 8, 2026High impedance

  IT WAS REPORTED THAT A DEEP BRAIN STIMULATION LEAD EXHIBITED AN IMPEDANCE ANOMALY (HIGH IMPEDANCES) PRIOR TO USE. NO DIAGNOSTICS OR TROUBLESHOOTING WERE PERFORMED. THE ISSUE WAS RESOLVED THROUGH GUARANTEE REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006475 ↗
• MalfunctionDec 23, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE FOR A PATIENT WITH ESSENTIAL TREMOR EXHIBITED A FAULTY LEAD. RED IMPEDANCE WAS DETECTED ON CONTACTS 1A AND 1B DURING TESTING, WHILE THE REST OF THE LEAD SHOWED GREEN IMPEDANCE. THE LEAD WOULD NOT PASS THE CONFIGURATION CHECK WITH THE LEAD TEST CABLE. TROUBLESHOOTING STEPS INCLUDED TWISTING AND RECONNECTING THE LEAD TEST CABLE, TESTING WITH AND WITHOUT THE MONOPOLAR CLIP, AND CONDUCTING IMPEDANCE CHECKS WITH THE ALPHA OMEGA SYSTEM, WHICH REPLICATED THE OPEN CONTACTS ON 1A AND 1B. THE LEAD WAS REMOVED AND REPLACED. THE ISSUE WAS RESOLVED AND THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881847 ↗
• MalfunctionDec 10, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE INDICATING THAT THE PATIENT HAD HIGH IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23765130 ↗

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.