SenSight™ B3400060MRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00763000426484), received between Aug 8, 2021 and Jun 19, 2026 — classified as 7 injuries, 19 malfunctions.

The most frequently reported specific device problem is “High impedance” (15 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026High impedance

  IT WAS REPORTED THAT PATIENT WAS IN A STAGE 2 IMPLANT CASE FOR A DBS SYSTEM. THEY HAD AN ISSUE WITH HIGH IMPEDANCE VALUE ON ELECTRODE 9A. THEY TESTED THE LEAD WITH THE LEAD TEST CABLE AND ENS, ALL IMPEDANCE INDICATORS WERE GREEN. WHEN THE EXTENSION WAS CONNECTED THE VALUE FOR 9A WAS HIGH AGAIN, THEY CONNECTED THE EXTENSION TO THE SECOND LEAD AND THE SAME SEGMENT ELECTRODE HAD A HIGH VALUE. THEY OPENED A SECOND EXTENSION AND IT SHOWED A HIGH VALUE FOR ELECTRODE 9A AND THE CORRESPONDING SEGMENT WHEN THE NEW EXTENSION WAS CONNECTED TO THE 0-3 LEAD. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECH SERVICES REVIEWED TROUBLESHOOTING CONSIDERATIONS. THE CALLER PLANNED TO GET ANOTHER EXTENSION. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THE CAUSE OF THE IMPEDANCES WAS UNKNOWN, BUT SUSPECT CONTRIBUTING FACTORS MAY HAVE INCLUDED INTERMITTENT ISSUE AND POSSIBLE POSITIONING OF PATIENT DURING SURGERY. REP REPORTED IMPEDANCES WERE NOT CLEARED DURING SURGERY. SURGEON COULD NOT CLEAR IMPEDANCE ISSUE ON 9A DURING SURGERY AND WAS TO ADD A NOTE THAT THEY WOULD PROVIDE THERAPY AROUND THE SEGMENT. SURGEON OPENED 3 M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25564991 ↗
• MalfunctionJun 19, 2026High impedance

  IT WAS REPORTED THAT PATIENT WAS IN A STAGE 2 IMPLANT CASE FOR A DBS SYSTEM. THEY HAD AN ISSUE WITH HIGH IMPEDANCE VALUE ON ELECTRODE 9A. THEY TESTED THE LEAD WITH THE LEAD TEST CABLE AND ENS, ALL IMPEDANCE INDICATORS WERE GREEN. WHEN THE EXTENSION WAS CONNECTED THE VALUE FOR 9A WAS HIGH AGAIN, THEY CONNECTED THE EXTENSION TO THE SECOND LEAD AND THE SAME SEGMENT ELECTRODE HAD A HIGH VALUE. THEY OPENED A SECOND EXTENSION AND IT SHOWED A HIGH VALUE FOR ELECTRODE 9A AND THE CORRESPONDING SEGMENT WHEN THE NEW EXTENSION WAS CONNECTED TO THE 0-3 LEAD. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECH SERVICES REVIEWED TROUBLESHOOTING CONSIDERATIONS. THE CALLER PLANNED TO GET ANOTHER EXTENSION. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THE CAUSE OF THE IMPEDANCES WAS UNKNOWN, BUT SUSPECT CONTRIBUTING FACTORS MAY HAVE INCLUDED INTERMITTENT ISSUE AND POSSIBLE POSITIONING OF PATIENT DURING SURGERY. REP REPORTED IMPEDANCES WERE NOT CLEARED DURING SURGERY. SURGEON COULD NOT CLEAR IMPEDANCE ISSUE ON 9A DURING SURGERY AND WAS TO ADD A NOTE THAT THEY WOULD PROVIDE THERAPY AROUND THE SEGMENT. SURGEON OPENED 3 M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25564936 ↗
• MalfunctionJun 19, 2026High impedance

  IT WAS REPORTED THAT PATIENT WAS IN A STAGE 2 IMPLANT CASE FOR A DBS SYSTEM. THEY HAD AN ISSUE WITH HIGH IMPEDANCE VALUE ON ELECTRODE 9A. THEY TESTED THE LEAD WITH THE LEAD TEST CABLE AND ENS, ALL IMPEDANCE INDICATORS WERE GREEN. WHEN THE EXTENSION WAS CONNECTED THE VALUE FOR 9A WAS HIGH AGAIN, THEY CONNECTED THE EXTENSION TO THE SECOND LEAD AND THE SAME SEGMENT ELECTRODE HAD A HIGH VALUE. THEY OPENED A SECOND EXTENSION AND IT SHOWED A HIGH VALUE FOR ELECTRODE 9A AND THE CORRESPONDING SEGMENT WHEN THE NEW EXTENSION WAS CONNECTED TO THE 0-3 LEAD. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECH SERVICES REVIEWED TROUBLESHOOTING CONSIDERATIONS. THE CALLER PLANNED TO GET ANOTHER EXTENSION. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP). REP REPORTED THE CAUSE OF THE IMPEDANCES WAS UNKNOWN, BUT SUSPECT CONTRIBUTING FACTORS MAY HAVE INCLUDED INTERMITTENT ISSUE AND POSSIBLE POSITIONING OF PATIENT DURING SURGERY. REP REPORTED IMPEDANCES WERE NOT CLEARED DURING SURGERY. SURGEON COULD NOT CLEAR IMPEDANCE ISSUE ON 9A DURING SURGERY AND WAS TO ADD A NOTE THAT THEY WOULD PROVIDE THERAPY AROUND THE SEGMENT. SURGEON OPENED 3 M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25564580 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT SURGEON WAS TUNNELING 3 EXTENSION WIRES AT ONCE. HE WAS INFORMED THAT THIS WAS OFF LABEL. HE INSERTED TWO EXTENSION WIRES INTO THE TUNNELER CARRIER PROPERLY. THE THIRD EXTENSION WIRE WAS TIRED TO THE END OF THE CARRIER WITH A SUTURE. AGAIN, HE WAS INFORMED THIS WAS OFF LABEL. AS HE WAS PULLING THE TUNNELER FROM THE CHEST POCKET THROUGH TO THE HEAD POCKET, EXTENSION WIRES BECAME STUCK ON TISSUE CAUSING THE TWO EXTENSION WIRES IN THE CARRIER TO BECOME FRAYED. THE WHITE SHEATH WAS STRIPPED BACK EXPOSING THE INTERNAL WIRES AND COMPLETELY COMPROMISING THE WIRES. THE THIRD EXTENSION WIRE REMAINED INTACT. NEW EXTENSION WIRES WERE OPENED AND IMPLANTED TO REPLACE THE BROKEN WIRES. THE SURGEON REQUESTED AN OFF LABEL SHUNT TUNNELER. HE PASSED EACH EXTENSION WIRE THROUGH A HOLLOW TUBE. ALL IMPEDANCES WERE NORMAL. MANUFACTURER REPRESENTATIVE (REP) INDICATES THE ISSUE WAS RESOLVED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25117422 ↗
• MalfunctionMay 1, 2026High impedance

  IT WAS REPORTED THAT IMPEDANCE WAS HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061966 ↗
• MalfunctionApr 24, 2026High impedance

  IT WAS REPORTED THAT THE EXTENSIONS ELECTRIC RESISTANCE WAS HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24980849 ↗
• MalfunctionApr 17, 2026High impedance

  IT WAS REPORTED THAT HIGH IMPEDANCE VALUES WERE IDENTIFIED DURING STAGE 1 INTRAOPERATIVE INTERROGATION OF THE IMPLANTED SYSTEM WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT-RELATED CONTRIBUTING FACTORS WERE IDENTIFIED. DURING TROUBLESHOOTING, THE EXTENSION WAS CONNECTED AND RECONNECTED TO THE IMPLANTED BATTERY MULTIPLE TIMES, AND HIGH IMPEDANCES PERSISTED. THE LEAD AND EXTENSION CONNECTION WAS THEN DISCONNECTED AND RECONNECTED, AFTER WHICH IMPEDANCES WERE CLEARED EXCEPT FOR ONE CONTACT THAT REMAINED ELEVATED. THE LEAD WAS TESTED INDEPENDENTLY AND DEMONSTRATED NORMAL IMPEDANCE VALUES. THE EXTENSION WAS THEN RECONNECTED TO THE LEAD AND TESTED AGAIN USING AN EXTENSION TEST CABLE, AT WHICH TIME THE SAME CONTACT CONTINUED TO SHOW ELEVATED IMPEDANCE. THE SURGEON REQUESTED THAT A NEW EXTENSION BE OPENED, AND ONCE THE NEW EXTENSION WAS CONNECTED AND TESTED, IMPEDANCE VALUES WERE FOUND TO BE WITHIN NORMAL RANGE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT, AND NO ADDITIONAL INFORMATION WAS EXPECTED FROM THE HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906468 ↗
• InjuryApr 15, 2026High impedance

  IT WAS REPORTED THAT PATIENT HAD ELEVATED IMPEDANCES ON ON RIGHT EXTENSION. DURING BATTERY CHANGE, ELEVATED IMPEDANCES WERE LOCALIZED TO THE RIGHT EXTENSION. EXTENSION WAS REPLACED AND ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885756 ↗
• InjuryMar 30, 2026Impedance Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT IMPEDANCE ISSUES ON ACTIVE CONTACTS AND THERAPY NO LONGER WORKING WAS OBSERVED. DIAGNOSTICS/TROUBLESHOOTING PERFORMED INCLUDED IMPEDANCE CHECK AFTER RESEATING THE LEAD, CHECKING AT THE EXTENSION USING AN EXTENSION TEST CABLE, AND CHECKING AT THE LEAD USING A LEAD TEST CABLE. IT WAS DETERMINED THAT THE FAILED IMPEDANCE WAS ATTRIBUTED TO THE EXTENSION. SURGICAL INTERVENTION WAS PERFORMED IN WHICH THE FAULTY EXTENSION WAS EXPLANTED/REMOVED AND A NEW EXTENSION WAS IMPLANTED; THE EXTENSION CAP WAS CUT OFF TO ALLOW REMOVAL OF THE EXTENSION THROUGH THE POCKET. AFTER IMPLANTATION OF THE NEW EXTENSION, IMPEDANCE TESTING WAS NORMAL AND THE IMPLANTABLE PULSE GENERATOR WAS DELIVERING THERAPY. THE ISSUE WAS REPORTED TO BE RESOLVED AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24730156 ↗
• MalfunctionDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT NO SET SCREW WAS IN THE EXTENSION. HCP USED THE EXTRA SET SCREW THAT COMES IN THE EXTENSION KIT TO LOCK THE EXTENSION INTO THE LEAD. NO PATIENT INJURY IS ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849635 ↗
• MalfunctionDec 11, 2025High impedance; High impedance

  ADDITIONAL INFORMATION WAS PROVIDED BY THE MANUFACTURER REPRESENTATIVE, INDICATING THAT STIMULATION WAS RUN ON THE SEGMENT FOR APPROXIMATELY 5 MINUTES WITH NO CHANGE TO THE HIGH IMPEDANCE, AND THE TEAM WILL RE-CHECK IMPEDANCES AT THE PATIENT¿S FIRST PROGRAMMING. THIS INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775329 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PLANNED PROCEDURE FOR DEVICE REPLACEMENT DUE TO BATTERY END OF LIFE, IT WAS DISCOVERED PATIENT EXPERIENCED SIGNIFICANT NECK DISCOMFORT OVER THE PAST SEVERAL YEARS LOCALIZED TO THE RIGHT SIDE IN THE LOCATION OF THE EXTENSION WIRE. THE EXTENSION WIRE WAS NOTED TO BE TAUGHT AND CLOSE TO SURROUNDING MUSCULATURE. THE DECISION WAS THUS MADE TO REPLACE THE EXTENSION AS WELL. THICK SCAR TISSUE WAS NOTED DURING PROCEDURE. ANTIBIOTICS WERE USED PREPHILATELY. PATIENT TOLERATED PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

  Patient problems: Adhesion(s); Discomfort; Scar Tissue

  MAUDE report 23645770 ↗
• InjuryNov 13, 2025High impedance; Impedance Problem; Material Deformation; High impedance; Impedance Problem; Material Deformation

  IT WAS REPORTED THAT IMPEDANCE ISSUE LEAD TO AN EXPLORATORY SURGERY TO FIGURE OUT WHERE THE IMPEDANCE ISSUES CAME FROM. TESTED LEAD WITH TEST CABLE. TESTED EXTENSION WITH TEST CABLE AND DETERMINED IT WAS A BROKEN TEST CABLE. APPEARED THAT THE EXTENSIONS WERE TWISTED, WHICH CAUSED THE BREAKAGE. RIGHT EXTENSION CABLE WAS REPLACED, WHICH FIXED THE IMPEDANCE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543738 ↗
• InjurySep 11, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING A STAGE II IMPLANT PROCEDURE, IMPEDANCE TESTING INITIALLY DISPLAYED NORMAL VALUES. HOWEVER, A FEW MINUTES LATER, MEASUREMENTS SHOWED MORE THAN 10,000 OHMS ON ALL COMBINATIONS FROM CONTACT 0. THE LEAD AND EXTENSION CONNECTION WERE DISCONNECTED AND RECONNECTED, AND IMPEDANCE VALUES RETURNED TO NORMAL. A SUBSEQUENT TEST AGAIN SHOWED >10,000 OHMS ON CONTACT 0. AFTER MULTIPLE DISCONNECTS AND RECONNECTIONS OF THE EXTENSION, THE INTERMITTENT IMPEDANCE ISSUES PERSISTED. THE SURGEON OPTED TO REPLACE THE EXTENSION. FOLLOWING THE IMPLANTATION OF A NEW EXTENSION, IMPEDANCE VALUES WERE CONSISTENTLY NORMAL ACROSS 15-20 TESTS. NO ENVIRONMENTAL OR EXTERNAL FACTORS WERE IDENTIFIED AS CONTRIBUTING TO THE ISSUE. THE ISSUE WAS RESOLVED, AND NO FURTHER INFORMATION IS AVAILABLE FROM THE HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034516 ↗
• MalfunctionSep 4, 2025High impedance; High impedance

  ADDITION INFORMATION WAS RECEIVED FROM THE MANUFACTURER REP INDICATING THAT IMPEDANCE FINDING RESOLVED ON THEIR OWN THE DAY FOLLOWING THE INITIAL REPORT WITH NO KNOWN ADDITIONAL ACTIONS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967117 ↗
• MalfunctionJul 2, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE INTERNAL AND EXTERNAL BOXES WERE DAMAGED WHEN THEY RECEIVED THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22381728 ↗
• MalfunctionApr 22, 2025High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS AN EXTENSION FAILURE DURING A DEEP BRAIN STIMULATION PROCEDURE. THE ISSUE WAS IDENTIFIED AS HIGH IMPEDANCE. THE EXTENSION WAS NEVER IMPLANTED, AND NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE RESOLUTION INVOLVED A GUARANTEED REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883439 ↗
• MalfunctionApr 21, 2025High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURING REPRESENTATIVE (REP). REP REPORTED THAT CAUSE OF HIGH IMPEDANCE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876305 ↗
• MalfunctionOct 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE MANUFACTURER REPRESENTATIVE (REP) THAT A SAMPLE DBS EXTENSION MARKED AS "SAMPLE NOT FOR HUMAN USE" WAS SHIPPED AS AN IMPLANT. WHEN SCANNED INTO THE INVENTORY SYSTEM, NO ALERT WAS GENERATED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20432221 ↗
• MalfunctionMar 18, 2024Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT EXTENSION WOULD NOT PASS CONFIGURATION TEST OR FUNCTION PROPERLY AT THE TIME OF ATTEMPTED IMPLANT. CIRCUMSTANCES TO EVENT WERE UNKNOWN. THE HEALTHCARE PROVIDER (HCP) TESTED STIMULATION THROUGH LEAD/EXTENSION, CONFIGURATION TEST, EXTENSION TEST CABLE. THE DEFECTIVE EXTENSION WAS REMOVED AT STAGE 2 AND REPLACED WITH NEW EXTENSION. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923239 ↗
• MalfunctionNov 28, 2022High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED THAT THE SURGEON HAD ISSUES CONNECTION THE EXTENSION AND LEAD TOGETHER. AFTER THE SURGEON CONNECTED EVERYTHING, IMPEDANCES SHOWED ALL OVER 5K. YOU COULD SEE THAT THE EXTENSION WAS NOT UP TO THE GRAY LINE ON THE LEAD. HE DISCONNECTED AND TRIED INSERTING THE LEAD FURTHER INTO THE EXTENSION, BUT IT WOULD NOT GO IN DEEPER. HE TRIED A FEW TIMES TO PUSH THE LEAD INTO THE EXTENSION WITHOUT ANY CHANGE. ACTIONS TAKEN TO RESOLVE ISSUE WERE THEY TRIED A NEW EXTENSION AND THE LEAD SLID INTO THE EXTENSION THE FIRST TIME WITHOUT ISSUE. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15873411 ↗
• InjuryNov 18, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT HCP COULD NOT GET THE LEAD TO INSERT INTO THE EXTENSION FULLY. THIS WAS APPARENT THROUGH AN IMPEDANCE TEST AS WELL AS MANUFACTURER REPRESENTATIVE (REP) AND HCP NOT BEING ABLE TO MEET THE INSERTION LINE MARKET ON THE LEAD ITSELF. NO CONTRIBUTING FACTORS WERE IDENTIFIED. HCP TOOK THE LEAD AND EXTENSION OUT MORE THAN FIVE TIMES AND TRIED RE-INSERTING BUT WAS UNABLE TO GET IT FULLY INSERTED. HCP THEN SWITCHED EXTENSION CABLES AND AFTER A FEW MORE TRIES WAS ABLE TO GET THE LEAD FULLY INSERTED INTO THE EXTENSION USING FORCEPS WITH RUBBER SHEATHS TO PROTECT THE LEAD. ACTIONS TAKEN TO RESOLVE THE ISSUE WERE REPLACING THE EXTENSION. THE ISSUE HAS BEEN RESOLVED. HCP SWITCHED OUT A NEW EXTENSION AND WAS ABLE TO FIT THE LEAD IN THE EXTENSION. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827956 ↗
• MalfunctionOct 2, 2022Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE SCRUB NURSE WAS USED TO USING BOSTON SCIENTIFIC EXTENSIONS WHERE THEY BACK THE SCREW OUR BEFORE INSERTION OF THE DBS LEAD. UNFORTUNATELY THE NURSE ALSO BACKED THE SCREWS OUT FOR OUR EXTENSIONS, ENOUGH SO THEY JUST STAYED IN PLACE UNTIL THEY WERE PULLED THROUGH THE NECK WHERE THEY BECAME DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526414 ↗
• InjuryAug 12, 2022High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED FROM A MANUFACTURER REPRESENTATIVE (REP) THAT THE LEAD WOULD NOT FIT DOWN THE EXTENSION. ANOTHER EXTENSION WAS OPENED AND THE LEAD FIT FINE. NO ENVIRONMENTAL ISSUES CONTRIBUTED TO THE ISSUE. THEY TESTED THE FITTING OF THE LEAD INTO ANOTHER EXTENSION AND IT FIT, EXTENSION WAS REPLACED. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15219144 ↗
• MalfunctionDec 17, 2021Component Missing; Component Missing

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE MISSING SETSCREW WAS THE ONE IN THE EXTENSION ITSELF. THE EXTRA SETSCREW THAT CAME IN THE SMALL PLASTIC BAG WAS PRESENT AND USED TO REPLACE THE MISSING ONE IN THE EXTENSION ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13029200 ↗

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.