DBS™ 3708660Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994749116), received between Feb 10, 2017 and Jun 5, 2026 — classified as 9 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

20 other recalls cover devices cleared under the same FDA submission (H020007, H050003, 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR NORMAL END OF SERVICE BATTERY REPLACEMENT TODAY. IN PRE-OP, ALL IMPEDANCES WERE NORMAL, HOWEVER, DURING THE PROCEDURE THERE WAS A SHORT (200 OHMS) DISCOVERED BETWEEN CONTACTS 8 AND 9 ON THE RIGHT HEMISPHERE. CALLER STATED THE PATIENT WAS PROGRAMMED WITH A DOUBLE MONOPOLE (C+ 8- 9-) ON THOSE CONTACTS. DURING THE PROCEDURE, THE EXTENSION TAILS WERE SWITCHED IN THE PORTS OF THE BATTERY AND IT WAS DETERMINED THAT THE ISSUE WAS RELATED TO THE LEAD OR EXTENSION AS OPPOSED TO THE BATTERY. THE PATIENT WASN'T CONSENTED FOR ANYTHING OTHER THAN THE BATTERY REPLACEMENT SO ONLY THE BATTERY WAS REPLACED TODAY. IN POST-OP, THE IMPEDANCE MEASUREMENT BETWEEN 8-9 HAD DECREASED TO 44 OHMS. CALLER STATED PROGRAMMING WAS LEFT AS IS ON C+ 8- 9- AND PATIENT APPEARED TO BE GETTING SYMPTOM CONTROL FOR TREMOR WITH IT NOTED THAT PATIENT WAS STILL COMING OFF SEDATION AT THE TIME. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. CALLER STATED (B)(6) UNIVERSITY WILL BE RETURNING THE EXPLANTED BATTERY. CALLER STATED THEY PLAN TO CHECK-IN WITH THE PATIENT IN A WEEK TO SEE HOW THEIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410069 ↗
• InjuryDec 12, 2025Impedance Problem; Adverse Event Without Identified Device or Use Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM REP INDICATING CAUSE OF THE REVISION ON (B)(6) WAS IMPEDANCES WERE DETECTED ON THE EXTENSION DURING A BATTERY REPLACEMENT PROCEDURE DUE TO BATTERY DEPLETION. IMPEDANCES WERE RESOLVED WITH EXTENSION REVISION.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23794657 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW IF ANY OF THE IMPLANTED COMPONENTS CONTAIN NICKEL AS THEY HAVE A SEVERE NICKEL ALLERGY. AGENT REVIEWED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) DOES NOT CONTAIN NICKEL. AGENT REVIEWED THAT ONE OF THE EXTENSION MATERIALS (STAINLESS STEEL) CONTAINS NICKEL THAT ONLY MAKES CONTACT WITH THE BODY DURING THE IMPLANT PROCEDURE. AGENT REVIEWED THAT ONE OF THE LEAD MATERIALS (MP35N) CONTAINS NICKEL THAT CONTACTS HUMAN TISSUE. IT WAS AT THIS POINT THAT THE PATIENT REPORTED THAT THEY HAVE HAD SEVERE MIGRAINES EVER SINCE THE LEADS WERE IMPLANTED. THE PATIENT STATED THAT THEY HAVE HAD SPONTANEOUS ANAPHYLACTIC REACTIONS AND MASSIVE MAST CELL ISSUES THAT HAVE GOTTEN INCREASINGLY WORSE SINCE THE LEADS WERE IMPLANTED. THE PATIENT STATED THAT THEY HAVE BEEN COMPLETELY DISABLED SINCE THE LEADS WERE IMPLANTED BECAUSE OF THE MIGRAINES, AND THEY HAD TO STOP WORKING. THE PATIENT STAT ED THAT THEIR WHOLE HEALTH DECLINED AND THEY HAVE OTHER HEALTH ISSUES AS WELL THAT THEY THINK MIGHT BE RELATED TO THIS EVENT. THE PATIENT NOTED THAT THEIR HEALTH ISSUES HAVE COMPLETELY RUINED THEIR LIFE AND ALLEGED THAT THE NICKEL IN THE LEADS WAS RESPONSIBLE FOR THEIR SUFFERI

  Patient problems: Anaphylactoid / Anaphylaxis; Headache; Hypersensitivity/Allergic reaction; Insufficient Information

  MAUDE report 23728773 ↗
• InjuryNov 3, 2025Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION WITH SOME MOVEMENT ON THE RIGHT SIDE OF THE BODY AND A SHOCKING SENSATION WITH PHYSICAL TOUCH TO THE LEFT SIDE OF THE POSTERIOR HEAD, OCCASIONALLY WHILE LAYING DOWN OR SLEEPING. IMPEDANCES WERE TESTED AND NO ABNORMALITIES WERE FOUND. ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE NOT KNOWN OR REPORTED TO THE MANUFACTURER REPRESENTATIVE (REP). EXTENSIONS WERE EXPLANTED AND NEW EXTENSIONS WERE IMPLANTED. THE ISSUE WAS RESOLVED.

  Patient problems: Electric Shock

  MAUDE report 23458334 ↗
• MalfunctionOct 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT  THE PATIENT HAD A TREMOR IN THEIR RIGHT ARM THAT WASN'T CONSTANT BUT WAS GOING OFF AND ON. PATIENT REP STATED THAT THE DAY AFTER THE PATIENT'S IMPLANT SURGERY, THE PATIENT HAS BEEN EXPERIENCING THIS ISSUE DAILY; NOT ALL DAY LONG, BUT THEY SEE SOME TREMOR EVERY DAY IN THE MORNING. PATIENT REP ALSO MENTIONED THAT THE TREMOR HAPPENS OCCASIONALLY THROUGHOUT THE DAY. PATIENT REP ADDED THAT THE SURGEON WHO IMPLANTED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS)  MENTIONED THAT THERE WAS A LITTLE BEND AROUND THE LEAD WIRE BECAUSE THE PATIENT HAD THE DBS FOR A WHILE. CALLER ALSO STATED THAT THE SURGEON HAD TO GO "ABOVE THAT BEND FOR THE RIGHT SIDE" BUT DID NOT CLARIFY WHAT THEY MEANT BY THAT. CALLER THEN CONFIRMED THAT THE PATIENT WAS ALREADY SCHEDULED FOR AN APPOINTMENT WITH THEIR NEUROLOGIST FOR NOVEMBER AND THAT THEY WERE JUST CALLING TO SEE IF THERE'S SOMETHING THEY CAN DO BEFOREHAND. AGENT REDIRECTED THE CALLER TO THE PATIENT'S HCP TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Shaking/Tremors

  MAUDE report 23414612 ↗
• MalfunctionMay 29, 2025Break; Break

  IN-HOUSE ANALYSIS OF THE EXTENSION FOUND THAT THE CONDUCTORS WERE BROKEN IN THE BODY OF THE EXTENSION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22109605 ↗
• InjuryNov 18, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ESSENTIAL TREMOR PATIENT HAD BOTH THEIR MEDTRONIC (MDT) BATTERIES REPLACED WITH A NON-MDT RECHARGEABLE BATTERY. DURING THIS PROCEDURE, THE MDT EXTENSION WIRES WERE TUNNELED ACROSS THE CHEST TO CONNECT TO THE NON-MDT RECHARGEABLE BATTERY. SHORTLY AFTER THE BATTERY REPLACEMENT SURGERY, THE SYSTEM "STOPPED WORKING". THE PATIENT WAS THEN BROUGHT BACK TO THE OPERATING ROOM (OR) AT ANOTHER TIME TO HAVE THE SYSTEM INTEGRITY VISUALLY CHECKED. IT WAS FOUND THAT THE LEFT MDT EXTENSION WIRE WAS NOT INTACT AND APPEARED SEVERED INTO TWO SEPARATE PIECES. THE LEFT EXTENSION WIRE WAS SUBSEQUENTLY REPLACED AND RECONNECTED TO THE NON-MDT BATTERY. THE ISSUE WAS RESOLVED WITH THE NON-MDT BATTERY REMAINING IN USE AND CONNECTED TO THE MDT LEADS AND EXTENSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20707806 ↗
• InjurySep 21, 2023Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE EXTENSION WAS IMPLANTED AND EXPLANTED IN THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787366 ↗
• MalfunctionApr 14, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY SPOKE WITH THE PATIENT TWO DAYS AFTER THE REPLACEMENT WHO STATED THINGS SEEMED TO BE WORKING WELL WITH NO MORE SHOCKING.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748172 ↗
• MalfunctionFeb 22, 2023Break; Break

  IT WAS REPORTED THAT POCKET WAS OPENED FOR REPLACEMENT SURGERY. THE SURGEON SAW A STITCH HAD BEEN PLACED THROUGH THE LEFT EXTENSION CABLE BY THE PREVIOUS SURGEON. NEW BATTERY IMPLANTED AND CONTACTS 2 AND 3 HAD LOW IMPEDANCES, AROUND 150. THESE WERE THERAPEUTIC CONTACTS SO SURGEON ELECTED TO START A NEW STAGE 2 SURGERY TO REPLACE THE EXTENSION. A NEW STAGE 2 WAS STARTED AND THE EXTENSION WAS REPLACED. THE PREVIOUSLY BAD CONTACTS HAD GREEN IMPEDANCES, BUT CONTACT 0 WAS HIGH AT 4000 OHMS. SURGEON ELECTED TO LEAVE IT AS IS SINCE IT¿S NOT USED BY THE PATIENTS THERAPY. ACTIONS TAKEN TO RESOLVE THE ISSUE WERE THE SURGEON ELECTED TO START A STAGE 2 IMMEDIATELY TO REPLACE THE EXTENSION. SURGERY WAS COMPLETED AND THE IMPEDANCES WERE BETTER ON THE USED CONTACTS, BUT THERE WAS A 4K IMPEDANCE ON AN UNUSED CONTACT. SURGEON SAID IT WAS FINE AND CLOSED. NO SYMPTOMS REPORTED. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416975 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE ISSUE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2021.

  Patient problems: Scar Tissue; Skin Erosion; Unspecified Infection

  MAUDE report 12165638 ↗
• InjuryApr 15, 2021Break; High impedance; Break; High impedance

  NO NEW INFORMATION.

  Patient problems: Muscular Rigidity

  MAUDE report 11671825 ↗
• MalfunctionJul 13, 2020Break; Break

  INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT WHILE THEY WERE REPLACING THE INS, THE LEFT EXTENSION BROKE. THE OLD EXTENSIONS WERE ALSO REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10263411 ↗
• MalfunctionMay 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEFT NECK IS STILL TIGHT AND SORE OVER THE EXTENSION WIRE. HE DOES SCRATCH THE AREA. EXTENSION SITE IS VERY TIGHT.

  Patient problems: Discomfort; Itching Sensation; Muscular Rigidity

  MAUDE report 10055907 ↗
• InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED AN MRI OF THE HEAD STATING THE HCP WAS UNAWARE OF THE PATIENT HAVING A BRAIN BLEED OR MINOR STROKE, AND ¿THINGS HAD GOTTEN WORSE¿ AND WAS ¿WEAK ON ONE SIDE.¿ THE PATIENT STATED THE EVENT WAS UNRELATED TO THE MRI, BUT HCP WAS UNSURE OF THE ROOT CAUSE OF THE INCIDENT. THE PATIENT STATED THE DBS WAS IMPLANTED TO TRIGEMINAL NEURALGIA. THE PATIENT MENTIONED THEY WORKED WITH THE DOCTOR BUT MOVED AND WAS UNSURE OF WHO TOOK THEIR PLACE. IT WAS RECOMMENDED FOR THE PATIENT TO CALL THE PREVIOUS MANAGING DOCTOR FOR ASSISTANCE IN FILLING OUT THE MRI FORM. THE PATIENT WANTED TO FIND AN HCP CLOSER BUT COULDN'T FIND A MANAGING PHYSICIAN FOR THEIR INDICATION.

  Patient problems: Intracranial Hemorrhage; Stroke/CVA; Weakness

  MAUDE report 9717575 ↗
• MalfunctionNov 25, 2019High impedance; High impedance

  IT WAS STATED THE PATIENT WAS HAVING ROUTINE BATTERY REPLACEMENT FOR ERI STATUS. A MANUFACTURING REPRESENTATIVE (REP) ATTENDED THE CASE. PRIOR TO THE INS CHANGE, IT WAS NOTED CONTACTS CASE AND 3 AND CASE AND 11 WERE HIGH. DURING THE INS CHANGE THE IMPEDANCES SHOWED HIGH VALUES ON CASE AND 3 CASE AND 1 AND ALL BIPOLAR CONFIGURATIONS. THE RIGHT SIDE SHOWED HIGH IMPEDANCES ON ALL CONTACTS. THE HCP DISCONNECTED AND RECONNECTED BOTH CHANNELS, AT WHICH TIME THE LEFT SIDE CONTINUED TO SHOW HIGH VALUES ON CASE AND 3 CASE AND 1 AND ALL BIPOLAR CONFIGURATIONS. THE RIGHT SIDE WENT BACK TO BASELINE WHICH WAS ON CASE AND 11 HIGH. THE HCP WAS WITH THE PATIENT POST-OP AS THEY WERE ABOUT TO BE DISCHARGED AND IN CHECKING IMPEDANCES AGAIN INDICATED SUMMARY TAB SHOWED CONTACTS 0, 2, AND 3 WITH XS AND "AVOID" AND CONTACT 1 WAS RED AND "NOT USED." IN ELECTRODE TAB, C-3 AND C-1 SHOW "HIGH" BUT C-2 AND C-0 SHOW 757 OHM; ALL BIPOLAR PAIRS SHOW "HIGH" WITH RED X'S. THE HCP STATED THE PATIENT WAS CURRENTLY PROGRAMMED ON C-0 AND IT WAS INQUIRED IF THEY HAD TO TURN THE INS OFF DUE TO THESE IMPEDANCE READINGS. IT WAS REVIEWED THAT IF THE PATIENT WAS CURRENTLY PROGRAMMING ON C-0, IT APPEARED THAT THE PAIR WAS O

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373817 ↗
• MalfunctionNov 25, 2019High impedance; High impedance

  IT WAS STATED THE PATIENT WAS HAVING ROUTINE BATTERY REPLACEMENT FOR ERI STATUS. A MANUFACTURING REPRESENTATIVE (REP) ATTENDED THE CASE. PRIOR TO THE INS CHANGE, IT WAS NOTED CONTACTS CASE AND 3 AND CASE AND 11 WERE HIGH. DURING THE INS CHANGE THE IMPEDANCES SHOWED HIGH VALUES ON CASE AND 3 CASE AND 1 AND ALL BIPOLAR CONFIGURATIONS. THE RIGHT SIDE SHOWED HIGH IMPEDANCES ON ALL CONTACTS. THE HCP DISCONNECTED AND RECONNECTED BOTH CHANNELS, AT WHICH TIME THE LEFT SIDE CONTINUED TO SHOW HIGH VALUES ON CASE AND 3 CASE AND 1 AND ALL BIPOLAR CONFIGURATIONS. THE RIGHT SIDE WENT BACK TO BASELINE WHICH WAS ON CASE AND 11 HIGH. THE HCP WAS WITH THE PATIENT POST-OP AS THEY WERE ABOUT TO BE DISCHARGED AND IN CHECKING IMPEDANCES AGAIN INDICATED SUMMARY TAB SHOWED CONTACTS 0, 2, AND 3 WITH XS AND "AVOID" AND CONTACT 1 WAS RED AND "NOT USED." IN ELECTRODE TAB, C-3 AND C-1 SHOW "HIGH" BUT C-2 AND C-0 SHOW 757 OHM; ALL BIPOLAR PAIRS SHOW "HIGH" WITH RED X'S. THE HCP STATED THE PATIENT WAS CURRENTLY PROGRAMMED ON C-0 AND IT WAS INQUIRED IF THEY HAD TO TURN THE INS OFF DUE TO THESE IMPEDANCE READINGS. IT WAS REVIEWED THAT IF THE PATIENT WAS CURRENTLY PROGRAMMING ON C-0, IT APPEARED THAT THE PAIR WAS O

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373808 ↗
• MalfunctionNov 25, 2019High impedance; High impedance

  IT WAS REPORTED THAT IN (B)(6) 2015 IMPEDANCES WERE DOCUMENTED AS CASE AND 2, 3, 10 AND 11 AS HIGH AND THERE WAS NO KNOWN REASON FOR THIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373776 ↗
• MalfunctionNov 25, 2019High impedance; High impedance

  IT WAS REPORTED THAT IN (B)(6) 2015 IMPEDANCES WERE DOCUMENTED AS CASE AND 2, 3, 10 AND 11 AS HIGH AND THERE WAS NO KNOWN REASON FOR THIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373771 ↗
• MalfunctionNov 25, 2019Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT (B)(6) 2015 NOTES FROM THE ACCOUNT STATES ABNORMAL IMPEDANCE BUT DID NOT SPECIFY ANY REASON OR WHICH CONTACTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373732 ↗
• MalfunctionNov 25, 2019Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT (B)(6) 2015 NOTES FROM THE ACCOUNT STATES ABNORMAL IMPEDANCE BUT DID NOT SPECIFY ANY REASON OR WHICH CONTACTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9373727 ↗
• InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE INFECTION RESULTED FROM PATHOGENS WHICH WERE NATIVE TO THE PATIENT'S SKIN. THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY VIA A PERIPHERALLY INSERTED CENTRAL CATHETER.

  Patient problems: Inflammation; Reaction; Seroma; Swelling; Unspecified Infection

  MAUDE report 7346197 ↗
• MalfunctionFeb 10, 2017Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN OUT OF BOX FAILURE. THE REPRESENTATIVE REPORTED THAT THE EXTENSION THAT WAS TO BE USED IN AN IMPLANT PROCEDURE WAS NEVER OPENED OUT OF THE STERILE PACKAGING BECAUSE IT WAS NOTED TO HAVE A SIGNIFICANT BEND IN THE PROXIMAL AREA. THE HEALTHCARE PROVIDER AGREED WITH THE REPRESENTATIVE AND THE EXTENSION IN QUESTION WILL BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6322057 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, H050003, 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.