NA 3708660Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00643169449152), received between Jun 23, 2017 and Aug 13, 2025 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “High impedance” (8 reports).

20 other recalls cover devices cleared under the same FDA submission (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.

• InjuryAug 13, 2025Low impedance; Low impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT A PATIENT EXPERIENCED AN IMPEDANCE ISSUE WITH THE EXTENSION CONNECTED TO THE LEFT-BRAIN LEAD, SHOWING IMPEDANCES OF LESS THAN 50 OHMS ON CONTACTS 0 AND 1. THE PATIENT REQUIRED MAGNETIC RESONANCE IMAGING (MRI), AND THE ABNORMAL IMPEDANCE READINGS PROMPTED THE NEED FOR INTERVENTION. IMPEDANCE TESTING WAS PERFORMED USING A TWIST CABLE LEAD KIT, WHICH SHOWED NORMAL RESULTS WHEN ISOLATING THE BRAIN LEAD. A NEW EXTENSION WAS IMPLANTED TO THE LEFT-BRAIN LEAD, AND SUBSEQUENT IMPEDANCE READINGS WERE NORMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796696 ↗
• InjuryJul 31, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE TIP OF THE EXTENSION CAME OFF WHEN IT WAS PULLED THROUGH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431462 ↗
• MalfunctionNov 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SAID THEIR DEVICE IS NOT TURNING ON AND NOT WORKING. THE ISSUE WAS NOT RESOLVED AT TIME OF REPORT. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822395 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEUROSTIMULATOR AND EXTENSION WERE EXPLANTED DUE REASON AS INFECTION. HOWEVER, DOCUMENT SHOWS INFORMATION THAT DIFFERENT FROM DEVICE REGISTRATION. THIS IS BEING FURTHER INVESTIGATED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10623037 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD EROSION OF THE RIGHT EXTENSION WIRE UP AND BEHIND THE EAR. THE CAUSE WAS UNKNOWN. A REPLACEMENT OCCURRED ON (B)(6) 2020 TO REPLACE THE RIGHT EXTENSION. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: Erosion

  MAUDE report 9859603 ↗
• MalfunctionMar 5, 2020Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S EXTENSION AND LEAD WERE DAMAGED. STAGE 1 AND STAGE 2 WERE PERFORMED ON THE SAME DAY. WHEN ATTEMPTING TO TIGHTEN THE SCREW ON THE EXTENSION/LEAD CONNECTION, ONE SCREW WOULD NOT TORQUE. WHEN ATTEMPTING TO TROUBLESHOOT, THE SURGEON REMOVED THE LEAD FROM THE EXTENSION AND CONTACT 0 CAME OFF THE LEAD AND WAS INSIDE THE EXTENSION. BOTH THE LEAD AND EXTENSION WERE REPLACED. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LEAD/EXTENSION WERE NEVER CONNECTED TO THE INS. THE DEVICES WERE SENT BACK FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9795250 ↗
• InjuryFeb 27, 2020High impedance; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem; High impedance; Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE REP RECEIVED AN EMAIL FROM AN HCP ON 2020-FEB-14. THE EMAIL STATED AN INTRA-OPERATIVE IMPEDANCE TEST HAD BEEN SCHEDULED FOR (B)(6) 2020. THE PATIENT HAD A LEAD FROM THIS MANUFACTURER AND A INS FROM BOSTON SCIENTIFIC. IT WAS UNKNOWN WHEN THE PATIENT CHANGED TO A BOSTON SCIENTIFIC INS. MORE INFORMATION WOULD BE AVAILABLE ON 2020-FEB-25. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WOULD FEEL SHOCKING EVERY TIME THEY MOVED THEIR HEAD. AN INTRA OP IMPEDANCE CHECK WAS CONDUCTED WITH ALLIGATOR CLIPS AND FOUND THE IMPEDANCES WERE HIGH AT THE EXTENSION AND WITHIN NORMAL RANGE AT ALL CONTACTS ON THE LEAD. THE EXTENSION WAS REPLACED, AS WELL AS THE INS AND THE IMPEDANCES WERE NORMAL.

  Patient problems: Electric Shock

  MAUDE report 9763290 ↗
• MalfunctionFeb 20, 2020Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT AN EXTENSION PURCHASED BY THE ACCOUNT WAS UNBOXED FOR USE AND THEY NOTICED THROUGH THE PLASTIC THAT THE EXTENSION LOOKED BENT IN THE WIRE NEAR THE END THAT ENTERS INTO THE HEADER BLOCK OF A DOUBLE INS. THE EXTENSION WAS NOT USED AND EXPECTED TO BE RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9733375 ↗
• MalfunctionDec 19, 2019Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT ACCORDING TO THE TABLET, THE IMPEDANCE WAS SHOWING OUT OF RANGE DURING STAGE TWO PROCEDURE. THE PHYSICIAN REMOVED AND REPLACED THE EXTENSION AND THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497626 ↗
• InjuryOct 11, 2019Break; Low impedance; Break; Low impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR DYSTONIA AND DEEP BRAIN STIMULATION (DBS) THERAPY INDICATIONS. IT WAS REPORTED THAT DURING THE STAGE 2 SURGERY IMPEDANCE TESTS WERE RAN INTRA-OP WITH FRESHLY IMPLANTED FULL DBS SYSTEM, CONTACTS IN FRONT CHANNEL (LEFT) WITHIN NORMAL LIMITS, CONTACT 9 & 10 IN POSTERIOR CHANNEL (RIGHT) IMPEDANCES "LOW". DIAGNOSTICS/TROUBLESHOOTING INCLUDED DOCTOR LOOSENING THE SET SCREW, IMPEDANCES WERE STILL "LOW". TRIED THE SAME SET OF EVENTS AGAIN, IMPEDANCES WERE "LOW". INSERTED LEFT LEAD INTO BACK CHANNEL, IMPEDANCES 8-11 WITHIN NORMAL LIMITS. DISCONNECTED RIGHT LEAD FROM EXTENSION OF SKULL, TESTED LEAD WITH TWISTLOCK = IMPEDANCES NORMAL. DOCTOR REMOVED BOTH EXTENSIONS FROM BODY. RE-TUNNELED WITH SAME LEFT EXTENSION AND NEW RIGHT EXTENSION. IMPEDANCES WERE ALL WITHIN NORMAL LIMITS. THE ISSUE IS REPORTED TO BE RESOLVED AT THE TIME OF EVENT. THE EXTENSION IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9182315 ↗
• MalfunctionOct 4, 2019High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT DURING THE STAGE 2 PROCEDURE HIGH IMPEDANCES WERE NOTED IN THE RIGHT STN, AFTER LEAD-EXTENSION CONNECTION AND EXTENSION BATTERY CONNECTION. THE EXTENSION WAS TAKEN OUT SEVERAL TIMES AND REINSERTED. IMPEDANCES REMAINED HIGH ON MOST CONTACTS. THEY ISOLATED THE RIGHT LEAD WITH AN ENS AND TWIST LOCK. ALL IMPEDANCES WERE NORMAL ON THE RIGHT LEAD. A NEW EXTENSION WAS OPENED AND IMPLANTED, AND ALL IMPEDANCES WERE NORMAL. THE ISSUE WAS RESOLVED. THE EXTENSION WOULD BE RETURNED FOR ANALYSIS. IT WAS ALSO NOTED THAT THE HIGH IMPEDANCES WEREN¿T AVAILABLE FROM THE TABLET DUE TO THE FILE NOT BEING ABLE TO BE OPENED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9154574 ↗
• MalfunctionSep 24, 2019Low impedance; Material Twisted/Bent; Insufficient Device Problem Information; Low impedance; Material Twisted/Bent; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), REGARDING A PATIENT UNDERGOING STAGE 2 IMPLANT. IT WAS REPORTED THAT THE SET SCREW FELT DIFFERENT WHEN TIGHTENING IT. AN IMPEDANCE CHECK WAS PERFORMED AND SHOWED A SHORT CIRCUIT BETWEEN 1 AND 2. ALL FOUR SCREWS WERE LOOSENED AND THE LEAD WAS WIPED DRY, BUT UPON REINSERTING AND TIGHTENING THE SET SCREW, THE HOUSE STARTED TO TWIST. THE HOUSING WAS LOOSE DESPITE THE HCP HOLDING THE SCREWBOX WHILE TIGHTENING. THE HCP DECIDED TO CHANGE OUT THE EXTENSION. THE NEW EXTENSION WAS IMPLANTED, ALL THE SET SCREWS WERE TIGHTENED WITHOUT ISSUE, AND THE IMPEDANCES WERE NORMAL. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9112654 ↗
• MalfunctionJul 5, 2019Device Damaged Prior to Receipt by User; Insufficient Device Problem Information; Device Damaged Prior to Receipt by User; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE SCREW WAS DISCARDED AND WOULD NOT BE RETURNED FOR ANALYSIS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8764771 ↗
• InjuryMay 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THERE WAS AN EXTENSION FAILURE. THERE WAS NO OTHER INFORMATION PROVIDED FROM THE HCP. THE REP NOTED THAT THEY WOULD REVIEW IMPEDANCES WHEN THEY SEE THE PATIENT AND HCP. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2019 E1 (REP): NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Response, Decreased

  MAUDE report 8638287 ↗
• MalfunctionApr 11, 2019High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE HIGH IMPEDANCE ON ALL CONTACT 1 COMBOS, EITHER 10K OR 20K. UNKNOWN IF ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. DIAGNOSTICS/TROUBLESHOOTING INCLUDED REPEATING IMPEDANCE TESTING AT VARIOUS VOLTAGES PRIMARILY 1.5 AND 3.0. INTERVENTIONS/ACTIONS INCLUDED REPLACING WITH ANOTHER EXTENSION. THE ISSUE IS REPORTED TO BE RESOLVED. DURING STAGE 2 BATTERY AND EXTENSION IMPLANT CASE, THE LEFTSIDE CONTACT 1 HAD HIGH IMPEDANCES WHEN INS WAS PLACED COMPLETELY IN POCKET. WHEN ONLY PARTIALLY INSERTED ALL IMPEDANCES WERE OKAY. SURGEON DECIDED TO REPLACE LEFT EXTENSION ONLY AND IMPEDANCES WERE OKAY EVEN WHEN FULLY INSERTED INTO POCKET. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8504505 ↗
• MalfunctionMar 21, 2019Break; Connection Problem; Break; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP)VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE TORQUE WRENCH WAS USED TO CONNECT EXTENSION TO LEAD IN STAGE 2 DEEP BRAIN STIMULATION (DBS) PROCEDURE, IN THE PROCESS OF TIGHTENING THE #2 CONTACT, THE FEMALE CONTACT CONNECTOR ROLLED INSIDE OF THE EXTENSION CONNECTOR HOUSING BEFORE THE TORQUE WRENCH ENGAGED. THIS CAUSED AN ABRUPT BENDING OF THE LEAD AT THE #2 CONTACT. NO KNOWN FACTORS THAT COULD HAVE LED TO OR CONTRIBUTED TO THE ISSUE WERE REPORTED. A VISUAL EXAMINATION OF DBS LEAD CONTACTS WAS PERFORMED AND THE CONTACT APPEARED TO BE DAMAGED. THE REP AND THE SURGEON THEN RECONNECTED THE LEAD AND PERFORMED ELECTRICAL INTEGRITY CHECK AND ALL CIRCUITS CAME BACK NORMAL. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT, HOWEVER THE PRIMARY CONCERN WAS WHETHER THE TORQUE WRENCH GIVES BEFORE ENOUGH TORQUE IS PRODUCED TO TURN THE EXTENSION CONNECTOR BLOCK. NO PATIENT SYMPTOMS REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8440118 ↗
• MalfunctionMar 7, 2019High impedance; Device Damaged Prior to Receipt by User; Connection Problem; High impedance; Device Damaged Prior to Receipt by User; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP)VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT IMPEDANCES ON ALL COMBOS WITH CONTACT 3 WERE HIGH BECAUSE THE LEAD COULD NOT SEAT PROPERLY IN THE CONNECTOR. THE SURGEON ATTEMPTED TO ADVANCE LEAD IN EXTENSION AND WAS NOT ABLE TO PASS ALL ELECTRODES THROUGH. THE SURGEON RE-OPENED SET SCREWS TO MAKE SURE ALL WERE OPEN ENOUGH TO PASS LEAD INTO EXTENSION CONNECTION BUT COULD NOT. A NEW EXTENSION WAS OPENED AND RE-TUNNELED, AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8399295 ↗
• MalfunctionFeb 28, 2019High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE FACILITY, REPORTED THERE WAS NO KNOWN REASON FOR THE HIGH IMPEDANCES. THE EXTENSION WAS STILL AT THE HOSPITAL AND WAITING ON PAPERWORK FOR RELEASE TO THE MANUFACTURER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378451 ↗
• MalfunctionFeb 8, 2019High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP)VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A STAGE II DEEP BRAIN STIMULATION IMPLANT. IT WAS REPORTED THAT DURING THE STAGE II PROCEDURE, THE EXTENSIONS WERE TUNNELED AND PLUGGED INTO THE PRIMARY CELL BATTERY. THE INITIAL IMPEDANCE CHECK WAS GOOD WITH ALL NORMAL VALUES. A SUBSEQUENT IMPEDANCE CHECK WAS DONE AFTER THE LEADS/EXTENSION AND BATTERY WERE FULLY TUCKED IN UNDER THE SKIN. ALL COMBINATIONS ON CONTACT 0 WERE HIGH. PROGRAMMER READ HIGH INDICATING A VALUE ABOVE 40,000. THE SURGEON TRIED DISCONNECTING THE EXTENSION FROM THE BATTERY AND RECONNECTED IT. THE HIGH STILL REMAINED ON ALL COMBINATIONS OF CONTACT 0. IT WAS INDICATED THAT THE SURGEON MANIPULATION OF THE EXTENSION COULD HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. WE DECIDED TO RE-TUNNEL AND PLACE A NEW EXTENSION TO REPLACE THE BAD ONE. THE NEW EXTENSION WAS PLACED AND TUCKED IN. ANOTHER IMPEDANCE CHECK SHOWED ALL NORMAL IMPEDANCE VALUES. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8320616 ↗
• InjuryAug 24, 2018Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP)VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT THE SURGEON WAS DOING A STAGE 2 TO CONNECT THE EXTENSION TO THE LEAD WHEN THEY WENT TO SCREW DOWN THE MOST PROXIMAL CONNECTION, IT DID NOT CLICK AND IT KEPT TURNING AND THEN STARTED SHREDDING AND RUINED/DESTROYED THE LEAD. SURGEON TRIED TO RECONNECT THE SCREW INTO THE LEAD AND IT JUST KEPT TURNING. THE SURGEON CUT THE LEAD AND THE EXTENSION WILL BE SENT BACK FOR ANALYSIS. A NEW STAGE 1 TO FIX THE LEAD WILL BE ON THURSDAY, (B)(6) 2018. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812539 ↗
• MalfunctionJul 26, 2018High impedance; Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT HIGH IMPEDANCES (16,000) WERE RECORDED DURING INTER-OP IMPEDANCES TESTING, THIS INVOLVED THE RIGHT EXTENSION AND WAS SPECIFIC TO CONTACT 8. THE DOCTOR EXPLAINED THAT THEY FELT THE SCREW SET ON THE HEADER BLOCK OF THE EXTENSION HAD SHIFTED. HIGH IMPEDANCES OCCURRED DURING STAGE LL DBS PROCEDURE. SURGEON REMOVED LEADS FROM BATTERY, WIPED THEM OFF AND REINSERTED TWICE. THIS DID NOT CLEAR UP THE IMPEDANCES SO THE DOCTOR REMOVED THE LEADS FROM THE EXTENSIONS AND DID THE SAME. AFTER REINSERTING, THE IMPEDANCES WERE TESTED AND AGAIN DID NOT RESOLVE. CONTACT 8 HAD IMPEDANCES OF 16,000 IN ALL THE ELECTRODE COMBINATIONS TESTED. THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED WITH TROUBLESHOOTING. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE REP NOTED THAT THEY WOULD RETEST THE PATIENT'S SYSTEM IMPEDANCES DURING THE INITIAL PROGRAMMING AND FOLLOW UP TO REPORT IF THEY HAVE RESOLVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7722806 ↗
• MalfunctionJul 11, 2018Crack; Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CUSTOMER HAD DISCARDED THE EXTENSION. THE INFORMATION WAS CONFIRMED WITH THE PHYSICIAN/ACCOUNT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7678688 ↗
• MalfunctionJun 14, 2018Connection Problem; Device Operates Differently Than Expected; Material Deformation; Connection Problem; Device Operates Differently Than Expected; Material Deformation

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IM PLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT THE EXTENSION SET SCREW/METAL CONTACT WAS BENT, FURTHER STATING THAT WHILE THE SURGEON WAS ATTACHING THE LEAD TO EXTENSION , THE EXTENSION METAL CONTACT WAS MOVING. THE SURGEON THOUGHT THE POTENTIAL FOR LEAD DAMAGE OR IMPEDANCES ISSUE COULD POTENTIALLY OCCUR. NO ENVIRONMENTAL/PATIENT FACTORS THAT MAY HAVE LED TO OR CONTRIBUTED TO THE ISSUE WERE REPORTED. A NEW EXTENSION WAS DURING THE PROCEDURE AND THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601903 ↗
• MalfunctionMar 8, 2018High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE CAUSE WAS UNKNOWN AND THE DEVICE WAS BEING RETURNED TO SEE IF THE CAUSE COULD BE FOUND. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323740 ↗
• MalfunctionSep 1, 2017Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THE HCP HELD EACH SCREW BOX AS THEY TIGHTENED THE SET SCREWS AND NOTICED ONE OF THE SCREEN ONES ROTATED 90 DEGREES. THEY WERE ABLE TO TWIST THE SCREW BOX BACK INTO THE CORRECT ORIENTATION. IMPEDANCES WERE CHECKED AND WITHIN NORMAL LIMITS. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6838721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.