SenSight™ B32000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00763000426521), received between Jun 29, 2021 and Sep 16, 2026 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793143 ↗
• MalfunctionMar 17, 2026Unstable

  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 24618303 ↗
• MalfunctionFeb 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT WHILE ATTEMPTING TO SECURE THE BASE PLATE TO THE SKULL, THE SCREW WENT THROUGH THE HOLE OF THE BASS PLATE, RATHER THAN ATTACHING TO THE BASE PLATE. A NEW BASE PLATE WAS OBTAINED AND THE ISSUE WAS RESOLVED. UPON OBSERVATION OF THE BASE PLATE ONE OF THE HOLES APPEARS LARGER THAN THE OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433144 ↗
• MalfunctionJan 19, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE LOCKING CAP CLASP WAS UNABLE TO LOCK. THE CAP WAS REPLACED ON THE SAME DAY TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111546 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT THE TRANSPARENT CAP OF THE BURR HOLE DEVICE CRACKED DURING A DEEP BRAIN STIMULATION PROCEDURE. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE ISSUE WAS 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 23908477 ↗
• MalfunctionSep 12, 2025Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A STAGE 1 DEEP BRAIN STIMULATION PROCEDURE ON THE RIGHT SIDE, THE BURRHOLE DEVICE PRESENTED DIFFICULTY SECURING THE RING BASE TO THE SKULL BECAUSE THE SCREW HOLE WAS TOO LARGE, ALLOWING THE SCREW TO PASS THROUGH WITHOUT SECURING THE BASE. ADDITIONALLY, THE CLIP COULD NOT BE LOCKED IN PLACE; THE CLIP WOULD CLOSE BUT NOT LOCK DESPITE MULTIPLE ATTEMPTS. THE PHYSICIAN TRIED TWO CLIPS ON THE STERILE FIELD, BOTH OF WHICH FAILED TO LOCK. A NEW BASE AND A NEW CLIP WERE PROVIDED, WHICH RESOLVED THE ISSUES, AND THE SCREWS SECURED THE BASE AS INTENDED. THE AFFECTED PRODUCTS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036287 ↗
• InjuryAug 15, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE SURGEON EXPERIENCED AN ISSUE WITH THE BURR HOLE DEVICE, AS THE WHITE PLASTIC LEAD RETENTION COMPONENT ("PAC MAN") WOULD LOCK CLOSED TEMPORARILY AND THEN POP BACK OPEN, FAILING TO RETAIN THE LEAD. THE BURR HOLE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE, RESOLVING THE ISSUE WITHOUT FURTHER INCIDENT. NO ENVIRONMENTAL OR EXTERNAL FACTORS CONTRIBUTED TO THE ISSUE, AND NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL. (B)(6) 2025: NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816461 ↗
• InjuryJul 14, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, A BURR HOLE WAS DRILLED IN AN INCORRECT LOCATION ON THE RIGHT SIDE OF THE SKULL DUE TO A LEKSELL FRAME SCREW NOT BEING SECURELY PLACED, WHICH PREVENTED ACCESS TO THE PLANNED TRAJECTORY AND TARGET. THE FRAME COORDINATES WERE CHECKED AND IT WAS DETERMINED THAT IT WAS NOT POSSIBLE TO REACH THE TARGET AT THE DESIRED TRAJECTORY. CONTRIBUTING FACTORS INCLUDED RUSHING AND FAILURE TO CHECK THE SCREW PLACEMENT WITH A FELLOW BEFOREHAND. TO CORRECT THE ISSUE, A NEW BURR HOLE WAS DRILLED TO ACHIEVE THE PLANNED TRAJECTORY AND TARGET, AND THE SAME BURR HOLE DEVICE WAS USED ALONG WITH A TITANIUM PLATING SCREW AND BURR HOLE COVER TO ADDRESS EXCESS SKULL NOT COVERED BY THE DEVICE. THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494732 ↗
• MalfunctionJun 9, 2025Unstable; Unstable

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, THE ELECTRODE CAP POST WAS NOT STRAIGHT AND THE ELECTRODE CAP COULD NOT BE SECURED PROPERLY. A NEW BURR HOLE DEVICE WAS USED ON THE SAME DAY TO COMPLETE THE SURGERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169011 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION PROCEDURE, A BRAIN BLEED OCCURRED INTRAOPERATIVELY. THE PATIENT EXPERIENCED COGNITIVE DEFICITS POST-OPERATION, ALTHOUGH THE EXTENT OF THESE DEFICITS IS CURRENTLY UNKNOWN. IT WAS BELIEVED THAT A BLOOD VESSEL WAS HIT DURING MICROELECTRODE RECORDINGS, WHICH CONTRIBUTED TO THE BRAIN BLEED. AFTER BURR HOLES WERE MADE AND DEVICES WERE PLACED, MICROELECTRODE RECORDINGS WERE PERFORMED, BUT NO BENEFICIAL RESULTS WERE OBSERVED, LEADING TO THE DECISION TO ABORT THE CASE. POST-OPERATIVE COMPUTED TOMOGRAPHY CONFIRMED THE BRAIN BLEED. NO SURGICAL INTERVENTION WAS PLANNED OR OCCURRED FOLLOWING THE EVENT. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: Cognitive Changes; Intracranial Hemorrhage

  MAUDE report 21915103 ↗
• MalfunctionMar 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BUR HOLE DEVICE BECAME DISENGAGED AND LEAD WENT 1.5 CM DEEP. HEARD AND FELT BUR HOLE DEVICE WAS LOCKED ON LEAD INITIALLY. HEALTHCARE PROVIDER WAS ABLE TO REENGAGE THE BUR HOLE DEVICE WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526557 ↗
• MalfunctionOct 14, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT DURING STAGE 1 SURGERY, THE SURGEON PLACED THE CLIP INTO THE BURR HOLE DEVICE RING, AND IT CLICKED INTO PLACE. THE SURGEON THEN CLOSED THE DOOR AROUND THE LEAD, WHICH ALSO CLICKED INTO PLACE, AND CONFIRMED THAT THE DOOR WAS SECURE. AFTER MARKING THE LEAD AND REMOVING THE STYLET, THE SURGEON REALIZED THAT THE CLIP HAD POPPED OUT OF THE BASE RING, EVEN THOUGH THE DOOR REMAINED CLOSED. THE SURGEON ATTEMPTED TO CLICK IT BACK INTO PLACE AND HAD SOMEONE HOLD IT THERE WHILE SECURING THE LEAD WITH A DOG BONE. THE REPRESENTATIVE ASKED IF THE SURGEON WANTED A NEW BURR HOLE DEVICE TO REPLACE THE CLIP, BUT THE SURGEON DECLINED AND PREFERRED TO SECURE IT WITH A DOG BONE. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS MAY HAVE LED TO OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT, AND THE HEALTHCARE PROFESSIONAL HAD NO FURTHER INFORMATION ABOUT THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436655 ↗
• MalfunctionSep 30, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT THE CLEAR TOOL USED TO HOLD THE V-CLIP HAD ITS ¿METAL END¿ SPLIT AFTER THE SCRUB TECH ATTEMPTED TO PLACE IT IN THE V-CLIP. THE TOOL IS BEING SENT BACK FOR ANALYSIS. THIS INCIDENT OCCURRED ON THE BACK SCRUB TABLE AT THE BEGINNING OF THE PROCEDURE, SO THE TOOL WAS NEVER USED WITH THE PATIENT. THE REP STATED THEY KNEW NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS CONTRIBUTING TO THIS POTENTIAL ISSUE. THE SCRUB TECH TRIED MULTIPLE TIMES TO INSERT THE METAL END OF THE CLEAR TOOL. SUBSEQUENTLY, THEY SWITCHED TO THE NEXFRAME V-CLIP TOOL, WHICH WORKED WITHOUT ANY ISSUES. AS A RESULT, ANOTHER BURR HOLE DEVICE KIT CLEAR TOOL WAS OPENED SINCE THE PHYSICIAN USED THE STARFIX PLATFORM AND NEEDED THE CLEAR TOOL TO FIT UNDERNEATH THE PLATFORM. THE NEW KIT CLEAR TOOL FUNCTIONED CORRECTLY, RESOLVING THE ISSUE. AT THE TIME OF THIS REPORT, THE PROBLEM WAS RESOLVED, AND THE HEALTHCARE PROFESSIONAL (HCP) HAD NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340708 ↗
• MalfunctionSep 13, 2024Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE BURR HOLE DEVICE CLIP WAS MISSING ONE OF THE THREE POLES ON ONE SIDE DESIGNED TO HOLD THE LEAD IN PLACE. THERE WERE NO CONTRIBUTING FACTORS. PRODUCT WAS OPENED ON THE STERILE BACK TABLE AND THE SURGEON NOTICED THAT IT DID NOT APPEAR AS IT SHOULD. A NEW BURR HOLE DEVICE KIT WITHOUT INSTRUMENTS WAS OPENED AS A REPLACEMENT. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213347 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT THE SCREW IN THE BURR HOLE KIT WENT STRAIGHT THROUGH THE BASE. CIRCUMSTANCES TO EVENT WERE UNKNOWN. THE SCREW AND BASE WERE REMOVED AND NEW ONES WERE USED. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861106 ↗
• MalfunctionApr 24, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SCREW HOLE OF THE BURR HOLE DEVICE WAS DAMAGED AFTER TRYING TO TIGHTEN THE SCREWS WITH THE CENTERING TOOL. NO CONTRIBUTING FACTORS WERE IDENTIFIED. THE HEALTHCARE PROVIDER (HCP) OPENED A NEW UNIT AND TOOK CARE TO AVOID OVERTIGHTENING THE SCREWS BY TIGHTENING MORE SLOWLY. THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16798875 ↗
• MalfunctionJun 7, 2022Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SCRUB TECH WAS UNABLE TO SECURE THE BLUE HANDLE CLIP TOOL INTO THE SMALL HOLE ON THE BURR HOLE CLIP. THE HOLE LOOKED LIKE IT WAS NOT PROPERLY PUNCHED ALL THE WAY THROUGH. AFTER TRYING MULTIPLE TIMES THEY WERE FINALLY ABLE TO GET THE TOOL INTO THE HOLE BUT THE MANUFACTURER'S REPRESENTATIVE (REP) DECIDED TO USE A DIFFERENT ONE SINCE IT WAS SO DIFFICULT. THE ISSUE HAS BEEN RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622668 ↗
• MalfunctionNov 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER SAYS THAT PUTTING THE BUR HOLE CAP ON IS CHALLENGING. IT DOESN¿T FEEL SECURE AND IF IT GOES ON IT ¿SPRINGS¿ BACK A BIT. THE PROVIDER DOES AN EXTRA STRAIN RELIEF LOOP AS EXTRA SECURITY EVEN THOUGH HE KNOWS IT¿S OFF LABEL. HE PUSHED ON CAP QUITE A BIT TO GET IT CLOSED BUT IT WAS STILL NOT SECURE IN HIS OPINION. THE MANUFACTURER REPRESENTATIVE REVIEWED OFF LABEL LOOP MAY BE CAUSING AN ISSUE, HOWEVER, THE PROVIDER DID NOT THINK IT WAS AS IT FIT THROUGH GROOVES OF CAP TO CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12825298 ↗
• MalfunctionJul 30, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT IN THE PROCEDURE, THEY WERE PUTTING ON THE CAP FOR THE BURR HOLE DEVICE AS PER PROTOCOL. THEY WERE NOT ABLE TO COMPLETELY SNAP THE CAP IN PLACE DESPITE SEVERAL ATTEMPTS. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. ULTIMATELY, THEY GOT A REPLACEMENT AND IT WENT ON WITHOUT ISSUE. THEY WERE ABLE TO IMMEDIATELY SECURE THE CAP. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252279 ↗
• MalfunctionJul 13, 2021Difficult to Open or Close; Difficult to Open or Close

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING TWO BURR HOLE DEVICES WERE OPENED, THE LEFT SIDE USED THE BASE AND COVER OF ONE FROM ANOTHER ONE AND ON THE RIGHT SIDE THEY SUCCESSFULLY USED THE CLIP OF THE FIRST BURR HOLE WITH A NEW BASE AND COVER. IT WAS CLARIFIED THE HCP WAS NOT FULLY CONFIDENT ABOUT THE SECURE CLOSING BY THE COVER OF THE BURR HOLE DEVICE. IN ADDITION, DUE TO THE HCP'S TECHNIQUE, THE FLOOR OF THE RECESS PLANAR CAN BE CURVED, NOT UNIFORMLY CURVED, BUT MANUALLY CURVED. THE FLOOR OF THE RECESS PLANAR COULD NOT BE SMOOTH BUT WITH LOCAL HIGH SPOTS. IT WAS INDICATED THAT THE CENTERING TOOL WAS NOT USED BY THE HCP, AND THE BASE RING MAY HAVE BEEN SLIGHTLY MISALIGNED WITH THE 14 MM BURR HOLE. THE SCREWS WERE REMOVED FROM THE CENTERING TOOL AND ALIGNED MANUALLY. THE ORIENTATION OF THE LINE RELATIVE TO THE PATIENT ANTERIOR-POSTERIOR AXIS WAS PARALLEL. THE ORIENTATION OF THE LINE RELATIVE TO THE SLIT BETWEEN THE CLIP JAWS WAS PARALLEL, AS WELL. THE HCP DID NOT USED THE JAWS AS A TROUBLESHOOTING TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158422 ↗
• MalfunctionJul 12, 2021Difficult to Open or Close; Difficult to Open or Close

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA THE MANUFACTURER¿S REPRESENTATIVE (REP), WHO REPORTED THE BURR HOLE CLIP WOULDN¿T STAY CLOSED INTRA-OPERATIVELY. THERE WERE NO KNOWN FACTORS THAT LED TO THE ISSUE. THE HCP TRIED MULTIPLE TIMES TO CLOSE THE CLIP, BUT THE ISSUE WASN¿T RESOLVED UNTIL IT WAS REPLACED WITH A NEW ONE FROM A DIFFERENT KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150496 ↗
• MalfunctionJun 29, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT IN THE MIDDLE OF A BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) IMPLANT, THE PHYSICIAN COULD NOT GET THE FINAL CAP/COVER TO FULLY ATTACH TO THE BURR HOLE DEVICE. THE PATIENT HAD A SMALL SKULL CAUSING GREATER THAN NORMAL CURVATURE. THEY TRIED TO UNLOCK AND LOCK THE SCISSOR MECHANISM TO MAKE SURE IT WAS FULLY LOCKED AND TRIED CLICKING THE COVER DOWN A DOZEN TIMES. THE PHYSICIAN DECIDED NOT TO USE THE COVER AND PUT A DOG BONE DOWN NEXT TO THE BURR HOLE DEVICE TO HOLD THE LEAD. THE FIRST SIDE WENT AS PLANNED. THEY THEN RAN AN IMPEDANCE TEST AND ALL LOOKED NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086391 ↗

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.