Vanta™ AdaptiveStim™ 977006Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00763000849078), received between Oct 23, 2024 and Sep 30, 2026 — classified as 33 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (20 reports).

1 FDA recall record name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (P840001); 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.

Recalls naming this device

1. Aug 21, 2024Open, Classified

   Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

   Z-0132-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock; Pain

  MAUDE report 50951954 ↗
• InjurySep 18, 2026Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Patient Device Interaction Problem

  Information was received from the manufacturer representative (rep) regarding an implantable device. The healthcare provider (hcp) let the rep know that the patient's lead had migrated again. HCP believed it was after patient was waking up from anesthesia and was thrashing violently in post op. HCP asked the rep to reprogram the patient to try and ¿salvage¿ the therapy. And if that didn¿t work, HCP would implant a different implantable neurostimulator (INS). Additional information was received from the rep. Rep met with the patient for a reprogram per HCP's request. All of the paresthesia was targeting patients right ribs, causing them extreme discomfort. Rep set the stimulator to 0mA, and turned off the device. Rep let the HCP know and HCP said they are going to proceed with implanting a different INS for the patient.

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue

  MAUDE report 50819116 ↗
• InjurySep 16, 2026Energy Output Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient reported that when the INS was implanted, they were doing well and their pain was well controlled. Pt was unsure whether the settings may have been adjusted incorrectly, as the vibration became very strong at night and prevented them from sleeping. Pt stated that they began lowering the intensity at night so they could sleep. Pt confirmed that the issue has been ongoing for two weeks. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Device Overstimulation of Tissue; Sleep Dysfunction

  MAUDE report 50789276 ↗
• InjuryAug 24, 2026Failure to Deliver Energy; Patient Device Interaction Problem

  Patient problems: Insufficient Information

  MAUDE report 50417997 ↗
• MalfunctionJul 17, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854755 ↗
• MalfunctionJul 15, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25826797 ↗
• InjuryJul 13, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR STATED THEY WERE EXPERIENCING SHOCKS THROUGHOUT THE LEGS, MOSTLY ON THE RIGHT SIDE, DURING STIMULATION, ALONG WITH SEVERE ITCHING ON THE RIGHT SIDE, NUMBNESS OF THE WHOLE RIGHT SIDE AFTER SITTING MORE THAN 15 MINUTES, INCREASED PAIN ATTRIBUTED TO THE IMPLANT, AND A CURRENT BLADDER PROBLEM. THE PATIENT STATED THEY HAD BEEN HAVING ISSUES WITH THE SCS DEVICE SINCE DAY 1 AND EXPRESSED INTENT TO HAVE THE IMPLANT REMOVED. THE PATIENT ALSO REPORTED EXTERNAL DEVICE ISSUES, INCLUDING A COMMUNICATOR THAT WOULD NOT POWER UP (NO LIGHT WHEN THE POWER BUTTON WAS PRESSED), A HANDSET NOT BEING FULLY CHARGED AS EXPECTED, AND INABILITY OF EXTERNAL DEVICES TO CONNECT TO THE SCS DEVICE DESPITE HAVING TWO SETS OF EXTERNAL DEVICES. THE PATIENT REPORTED THAT STIMULATION HAD BEEN ADJUSTED AT A PRIOR VISIT, BUT SHOCKS PERSISTED, AND THE PATIENT NEEDED THERAPY TURNED OFF FOR AN UPCOMING SURGERY. DURING ONE CALL, THE PATIENT REFUSED TROUBLESHOOTING AND DISCONNECTED THE CALL. DURING A SUBSEQUENT CALL, THE AGENT WALKED THE PATIENT THROUGH CONNECTING TO THE MYSTIM APPLICATION, AND THE PATIENT SUCCESSFULLY CONNECTED AND TURNED THERAPY OFF, AFTER

  Patient problems: Electric Shock; Insufficient Information; Itching Sensation; Numbness; Pain

  MAUDE report 25803914 ↗
• MalfunctionJul 13, 2026Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock; Pain

  MAUDE report 25798837 ↗
• MalfunctionJun 17, 2026Unintended Collision; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT STUMBLED AND FELL DOWN A DRIVEWAY INTO A DITCH AFTER A WALKER HIT A ROCK. A DEVICE ISSUE WAS REPORTED IN WHICH THE 0¿7 LEAD READ AS NOT CONNECTED. CONNECTIVITY WAS CHECKED TWICE, AND THE 0¿7 LEAD CONTINUED TO READ NOT CONNECTED. THE ISSUE WAS REPORTED AS RESOLVED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534415 ↗
• InjuryJun 9, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THE PATIENT'S DEVICE WAS NOT AT END OF LIFE, THE IMPLANT BATTERY WAS AT ABOUT 80% BATTERY LIFE REMAINING. REP REPORTS PER THE DOCTOR THE PATIENT WAS REPORTING THAT "IT WASN'T WORKING", AND THE PHYSICIAN ELECTED TO REMOVE IT AFTER DISCUSSING THIS WITH THE PATIENT. REP REPORTS THE CAUSE WAS UNKNOWN, NO TROUBLESHOOTING ACTIONS WERE TAKEN, AND THE DEVICE WAS TURNED ON WHEN THEY INTERROGATED THE DEVICE. REP REPORTS THE PHYSICIAN DID NOT ALLOW THEM TO ASK THE PATIENT ANY ADDITIONAL FOLLOW UP INFORMATION. IT WAS UNCLEAR IF THE DEVICE NEVER "WORKED" FOR THE PATIENT OR IF THE PATIENT EXPERIENCED A CHANGE IN THERAPY/DEVICE ISSUE. REP REPORTS THE ISSUE WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 25449040 ↗
• MalfunctionJun 8, 2026Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PT REPORTED PAIN/SHOCK ON THE SIDE WHERE THE SPINAL CORD STIMULATOR IS LOCATED SINCE YESTERDAY. PT NOTED THEY WERE HAVING BACK PAIN AND NEEDED ASSISTANCE TO NAVIGATE. PT MENTIONED THE STIM IS ON THE LEFT SIDE BUT NOW THE PAIN WAS ON THEIR RIGHT SIDE. AGENT INSTRUCTED PT TO CONNECT TO THEIR THERAPY SETTINGS BUT THE HANDSET SHOWED NOT FOUND COMMUNICATOR. AGENT WALKED PT THROUGH CLOSING ALL APPLICATIONS AND RESETTING THE COMMUNICATOR. PT THEN TRIED TO CONNECT TO THE MYSTIM APP AND PATIENT CONFIRMED THEY WERE ABLE TO CONNECT TO THEIR THERAPY SETTINGS. PT WAS ON GROUP A AT 1.0, AGENT WALKED PT THROUGH INCREASING THE STIMULATION AND PT CONFIRMED THEY CAN'T FEEL THE STIMULATION. AGENT ASKED AND PT CONFIRMED THEY ONLY HAVE GROUP A. THE PT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Electric Shock; Pain

  MAUDE report 25435555 ↗
• MalfunctionJun 2, 2026Failure to Deliver Energy; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEY WERE ONLY GETTING STIMULATION DOWN THEIR LEG INSTEAD OF THEIR BACK AND THE ISSUE BEGAN ABOUT 6 TO 8 MONTHS AGO. PATIENT STATED THEY HAD THEIR DOCTOR PUT WIRES IN FOR A PAIN PUMP. AFTER THAT THE THERAPY STOPPED WORKING. PATIENT DIDN'T KNOW IF THEY DISCONNECTED OR WHATEVER WHEN THEY PUT THE PAIN PUMP WIRES IN BUT PATIENT HAD BEEN HAVING PROBLEMS EVER SINCE. PATIENT TURNED ON GROUP A, B, AND C AND TURNED THEM UP BUT PATIENT STILL DIDN'T GET STIMULATION IN THEIR BACK AREA. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 25364655 ↗
• InjuryJun 1, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT TWO LEADS MIGRATED, AND A LEAD REVISION SURGERY WAS PERFORMED. THERE WERE NO REPORTED IMPEDANCE ABNORMALITIES, FRACTURES, OR OTHER ISSUES WITH THE ORIGINAL IMPLANTED LEADS, BUT THE PHYSICIAN OPTED TO EXPLANT THE ORIGINAL TWO LEADS AND IMPLANT TWO BRAND NEW LEADS. THE ISSUE WAS REPORTED AS RESOLVED, AND THE PATIENT WAS ALIVE WITH NO INJURY. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25354371 ↗
• MalfunctionMay 25, 2026Energy Output Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PT REPORTED THAT LAST NIGHT THE HANDSET SCREEN WAS GETTING STUCK ON CONNECTING. PT REPORTED THEY TRIED CANCELLING AND CLOSING OUT OF THE APPS BUT THAT DID NOT RESOLVE THE ISSUE. PT REPORTED THAT THEY COULD NOT SLEEP BECAUSE THEY WERE NOT ABLE TO ADJUST THE STIMULATION AND IT WAS UNCOMFORTABLE TO SLEEP. DURING THE CALL PT COULD NOT POWER ON HANDSET SCREEN. PT ATTEMPTED TO CONFERENCE HCIT, BUT PT WAS THEN ABLE TO TO GET THE SCREEN TO POWER ON. PT THEN RESET THE COMMUNICATOR AND CLOSED OUT OF THE APPLICATIONS. THE SAME ISSUE PERSISTED. PT RESET THE HANDSET AND RESET THE COMMUNICATOR. PT CLOSED OUT OF THE APPS AND TOGGLED BLUETOOTH ON AND OFF. PT REMOVED THE COMMUNICATOR AND THEN ATTEMPTED TO RE-PAIR THE COMMUNICATOR. PT REPORTED THE BLUE LIGHT WOULD NOT POWER ON. PT WAS UNABLE TO CONNECT TO GET THE SCREEN TO ADVANCE PAST CONNECTING. AGENT SENT A REQUEST TO REPAIR TO REPLACE THE COMMUNICATOR. PT REPORTED THAT THEY HAD SURGERY BECAUSE OF BLOOD CLOTS IN THEIR BRAIN. PT REPORTED THEY HAD TO HAVE ANOTHER OPERATION TO PREVENT THE CLOTS FROM SPREADING. PT REPORTED THEY WERE IN THE HOSPITAL FOR

  Patient problems: Ambulation or Postural Difficulties; Sleep Dysfunction

  MAUDE report 25268536 ↗
• InjuryMay 8, 2026Intermittent Continuity; Failure to Deliver Energy; Energy Output Problem; Battery Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT PT AND THE PHYSICIAN HAD PREVIOUSLY AGREED TO DO JUST AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT BECAUSE PATIENT REPORTED HER OLD INS WAS DEAD AND NO LONGER WORKING. THE PATIENT REPORTED TO THE PHYSICIAN THAT SHE THOUGHT HER BATTERY WAS DEAD (EOS) AND THAT¿S WHY SHE WASN'T ABLE TO FEEL STIMULATION OR USE HER DEVICE ANY LONGER. THE INS WAS NOT AT EOS. REP ASKED PATIENT MANY QUESTIONS REGARDING THE THERAPY PRIOR TO WHEN SHE THINKS HER INS DIED. SHE STATED SHE WAS HAVING PROBLEMS FEELING STIMULATION AND "GETTING IT TO WORK." WHEN ASKED TO ELABORATE, SHE STATED THE STIMULATION DIDN'T ALWAYS COME ON LIKE IT WAS SUPPOSED TO AND SHE WOULD HAVE TO HOLD HER NECK OR BODY A CERTAIN WAY TO FEEL ANY STIMULATION AND THEN AT BEST IT WAS INTERMITTENT. THE ISSUE IS ONGOING. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. SEE (B)(4) FOR HIGH IMPEDANCES, FUTURE LEAD REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 25125567 ↗
• InjuryMay 6, 2026Failure to Deliver Energy; High impedance

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A RETURN OF PAIN AND LOSS OF STIMULATION IN THE SETTING OF A HIGH IMPEDANCE ISSUE. HIGH IMPEDANCE WAS OBSERVED ON THE DAY OF SURGERY, WITH IMPEDANCE VALUES OF 40,000 REPORTED FOR CONTACT 6 AND CONTACTS 8¿15. TROUBLESHOOTING WAS PERFORMED WITH REPROGRAMMING ON 0¿7 LEAD. THE ISSUE WAS REPORTED AS RESOLVED FOLLOWING DEVICE REVISION WITH FULL SYSTEM EXPLANT, EXPLANT OF TWO LEADS, AND IMPLANTATION OF A NEW SURGICAL LEAD AND A NEW IMPLANTABLE PULSE GENERATOR (IPG). THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE CLINICAL SPECIALIST MET THE PT DAY OF SURGERY AND HOOKED UP TO THE PATIENT WHERE THEY NOTED THE CONTACTS HAD MOVED OUT, REP CLARIFIED BY MOVED OUT THEY WERE REFERRING TO IMPEDANCES, UNKNOWN IF THERE WAS MIGRATION. THE CS PUT THE SEPTEMBER DATE AS THAT WAS THE DATE THE SURGERY HAD BEEN SCHEDULED BUT CLARIFIED NO AWARENESS OF ISSUE/PATIENT/DEVICE INFO PRIOR. REP AND CS INDICATED HAD THEY BEEN AWARE OF A COMPLAINT PRIOR THEY WOULD HAVE SUBMITTED IT. SURGERY DATE CONFIRMED AS (B)(6) 2026.

  Patient problems: Pain

  MAUDE report 25096055 ↗
• MalfunctionApr 20, 2026Energy Output Problem

  IT WAS REPORTED THAT PATIENT(PT)S COMMUNICATOR WAS NO LONGER WORKING AS OF TUESDAY. THEY SPOKE TO THE REPRESENTATIVE(REP) AND THEY TRIED SWAPPING OUT THE CORD BUT THAT DID NOT WORK. PT WAS VIBRATING ON HER BACK FOR TWO DAYS (AGENT UNDERSTOOD PT WAS EXPERIENCING STIMULATION). IT WAS NOT A FUN THING SINCE PT WAS VIBRATING WHEN TRYING TO SLEEP. WHEN PT WAS TRYING TO USE THE COMMUNICATOR THEY GOT A MESSAGE THAT SAID TO TURN COMMUTATOR ON BUT IT WOULD NOT TURN ON. DURING CALL CALLER CLOSED ALL APPLICATIONS AND POWERED OFF THE HANDSET. CALLER HELD THE COMMUNICATOR POWER BUTTON DOWN FOR AN EXTENDED PERIOD OF TIME. CALLER PLUGGED THE COMMUNICATOR INTO THE CHARGING CORD AND TRIED A DIFFERENT OUTLET, BUT COMMUNICATOR WOULD NOT TURN ON OR CHARGE. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Paresthesia

  MAUDE report 24921772 ↗
• MalfunctionApr 15, 2026Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PT REPORTED THE SPINAL CORD STIMULATOR DID NOT HELP THEIR ISSUE AND IT WOULD SHOCK THEM. AGENT REVIEWED WITH THE PATIENT THAT THEY WOULD NEED TO WORK WITH A PHYSICIAN WHO WORKS WITH THE MANUFACTURER'S DEVICES. AGENT OFFERED TO SEND A PHYSICIAN LISTING TO THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Electric Shock

  MAUDE report 24886998 ↗
• MalfunctionApr 8, 2026Energy Output Problem; Vibration

  INFORMATION WAS RECEIVED FROM PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT STATED THAT THEIR DEVICE WAS WORKING FINE SINCE MAY AND THEY TRY TO CONTACT MANUFACTURER REPRESENTATIVE (REP) FROM PHOENIX BUT UNABLE TO GET A HOLD OF HER. PATIENT MENTIONED THAT IT WAS WORKING FINE NOT UNTIL RECENTLY THAT THEY GOT HOSPITALIZED. PATIENT WAS IN THE HOSPITAL LAST WEEK FOR 3 DAYS DUE TO A HEART CONCERN. DURING THE CALL PATIENT WAS PROVIDING SEVERAL HISTORICAL EVENTS. PATIENT MENTIONED THAT IT MIGHT BE DUE TO THE AMBULANCE THEIR BACK WAS TWISTED AND IT WAS NOT WORKING RIGHT. PATIENT STATED THAT NOW ALL OF A SUDDEN THEY HAVE PAIN AND THEY ARE NOT GETTING ANY RELIEF. PATIENT MENTIONED THAT THEY ALREADY TRIED MAKING AND ADJUSTMENT. THEY ALSO MENTIONED THAT MAKING AN ADJUSTMENT ON THE INTENSITY WAS DIFFICULT FOR THEM AS THEY HAVE TROUBLES CONNECTING TO THEIR THERAPY APPLICATION. PATIENT STATED THAT THEY MANAGED TO MAKE AN ADJUSTMENT OVER THE WEEKEND AND THEY GOT IT TO INTENSITY AROUND 4 AND IT WAS FINE FOR THEM FOR A WHILE BUT AFTER A LONG TIME IT WAS WAY TOO STRONG FOR THEM. AGENT ASSISTED PATIENT TO ACCESS MYSTIM APP BUT THEY KEEP GETTING ROUTED TO S

  Patient problems: Device Overstimulation of Tissue; Pain; Shaking/Tremors; Sleep Dysfunction

  MAUDE report 24824616 ↗
• MalfunctionMar 30, 2026High impedance; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Unstable; Material Deformation

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT AN X-RAY HAD SHOWED THAT A PATIENT'S LEAD HAD MIGRATED. THE PATIENT ALSO NOTED THAT THEY WERE NO LONGER GETTING RELIEF AND EXPERIENCED A RETURN OF PAIN, AT THE INS SITE. THE PATIENT HAD ALSO NOTED THAT THE INS HAD MOVED IN THE POCKET. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED SHOCKING AND STIMULATION IN AN INCORRECT LOCATION. HIGH IMPEDANCES WERE FOUND ON A SINGLE ELECTRODE (# 15: 40,000). TROUBLESHOOTING INCLUDED AN ATTEMPT TO PROGRAM TO COVER THE PAIN WITH THE NEW LEAD LOCATION. THE ISSUE WAS ONGOING.

  Patient problems: Electric Shock; Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 24730379 ↗
• MalfunctionMar 23, 2026Unintended Collision; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ELECTRICAL SHOCK SENSATION RADIATING THROUGH THE RIGHT ARM FOLLOWING A FALL. THE SENSATION WAS UNCOMFORTABLE ENOUGH THAT THE PATIENT TURNED OFF STIMULATION. THERE WAS A SUSPICION OF POSSIBLE LEAD MIGRATION, PENDING IMAGING CONFIRMATION. OUTPATIENT CERVICAL X-RAYS WERE ORDERED TO ASSESS LEAD POSITIONING, AND AN IMPEDANCE CHECK WAS CONDUCTED, WHICH WAS WITHIN NORMAL LIMITS. NEW PROGRAMMING WAS PROVIDED TO RECAPTURE THE RIGHT ARMPIT AND THE AREA FROM THE RIGHT SHOULDER TO THE ELBOW WITHOUT THE PREVIOUSLY UNCOMFORTABLE STIMULATION. THE PATIENT WAS SCHEDULED TO COMPLETE X-RAYS AND FOLLOW UP WITH THE MANAGING PHYSICIAN FOR ADDITIONAL REPROGRAMMING AS NEEDED. THE ISSUE WAS ONGOING, AND THE PATIENT REMAINED ALIVE WITH NO INJURY. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE. ADDITIONAL INFORMATION WAS RECEIVED F ROM THE MANUFACTURER REPRESENTATIVE (REP) STATING THE PATIENT HAD X-RAYS COMPLETED ON (B)(6) 2026. THERE WAS NO NOTABLE LEAD MIGRATION THAT WOULD WARRANT A SURGICAL REVISION AND THAT THE LEADS ACTUALLY APPEAR TO BE MORE MIDLINE THAT INITIAL IMPLANT X-RAY. THE PATIENT IS STIL

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Electric Shock; Inappropriate Device Stimulation of Tissue

  MAUDE report 24665219 ↗
• MalfunctionMar 11, 2026Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THAT THEY TURNED THEIR THERAPY OFF ON FRIDAY AND NOW THEY NEED ASSISTANCE TURNING STIMULATION BACK ON. AGENT WALKED PATIENT THROUGH CONNECTING TO THEIR SETTINGS AND PATIENT CONFIRMED THAT THERAPY WAS ON, BUT THEY WERE NOT FEELING THE STIMULATION. PATIENT INCREASED THERAPY TO 2.8 BUT FELT NO STIMULATION. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24568921 ↗
• MalfunctionFeb 27, 2026High impedance

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 24470731 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM WAS RETURNED WITH PAPERWORK NOTING HARDWARE REMOVAL DUE TO INFECTION ON (B)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 24469296 ↗
• MalfunctionFeb 19, 2026Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED, PATIENT REP STATED THAT FOR SOME REASON THE STIMULATOR WAS NOT WORKING PROPERLY. PATIENT REP STATED THAT THIS MORNING THEY HAVE A CALL AND TEXT SAYS IT WAS MANUFACTURER AND SAYING THEIR DEVICE WAS DISCONNECTED. PATIENT REP STATED THAT PATIENT CAN BARELY WALK AND A LOT OF PAIN. PATIENT HAS THE DEVICE WITH THEM AND CONFIRMED THAT THEY ARE IN GROUP A WITH THERAPY ON. PATIENT ALREADY TRIED CHANGING THE INTENSITY SETTING BUT THEY ARE STILL FEELING A LOT OF STIMULATION ON THEIR LEFT LEG BEFORE IT WAS KIND OF SOOTHING BUT NOW IT WAS LIKE A JOLT. PATIENT MENTIONED LAST NIGHT THEY LOWER THE INTENSITY TO 1.2 AND WHEN THEY LAY DOWN OR STRETCH IT GIVES THEM A HIGH PAIN. PATIENT ALSO MENTIONED GETTING SHOCK.

  Patient problems: Ambulation or Postural Difficulties; Electric Shock; Pain

  MAUDE report 24388033 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. One submission often covers many models, so check the product and lot details in each record.

• 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-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis