Vanta™ AdaptiveStim™ 977006 (UDI 00763000964153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 00763000964153), received between Jun 4, 2025 and Sep 30, 2026 — classified as 51 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (30 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Migration or Expulsion of Device

  Information was received from a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (INS). They reported that the patient's paddle lead migrated by one vertebral body and this was revised this morning. They kept the same paddle as the first implant and just adjusted the paddle lead today. Revision was completed successful. The follow up appointment is (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951797 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Energy Output Problem

  Information was received from Patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient (Pt) reported that when the intensity was increased to 12.6 from 11.4 in Group A, they could not feel stimulation on the right side but could feel it on the left side. Pt stated they could not get it to work on both sides. Pt also stated that they tried switching to Group B and increased the intensity to 9.5 from 9.4 and they felt the stimulation in their back and down their legs, although the intensity was set at around 8. Pt noted that Group C did not work at all at an intensity of 4 and stated that they were unable to change it. Pt also stated that no error message was received. Pt also noted they were not using Group B that much and mostly used Group A. Patient mentioned they were in so much pain. Agent reviewed information. The pt was redirected to their HCP.

  Patient problems: Pain

  MAUDE report 50947142 ↗
• InjurySep 29, 2026Electromagnetic Interference

  It was reported that patient had increased pain and numbing in upper extremities after a lumbar MRI. They reported that the pain increased by turning on the implantable neurostimulator (INS). Patient met with manufacturer representative (rep) for reprogramming. Issue is ongoing. The relationship of the event to the device or therapy is causal but it is not related to the implant procedure.

  Patient problems: Numbness; Pain

  MAUDE report 50931858 ↗
• InjurySep 28, 2026Migration or Expulsion of Device

  Patient problems: Discomfort

  MAUDE report 50916341 ↗
• InjurySep 25, 2026Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient experienced new urinary incontinence, a shocking sensation in the left leg, and potential lead dislodgement. The patient was evaluated in the emergency department and was currently in the emergency department. The healthcare provider (HCP) ordered magnetic resonance imaging for diagnostic evaluation. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Electric Shock; Incontinence

  MAUDE report 50897923 ↗
• InjurySep 25, 2026Failure to Deliver Energy

  Information was received from patient regarding an external device. The reason for the call was that the patient reported they were unable to connect to their implantable neurostimulator (INS) , and the screen would only show "Connecting." During the call, the agent instructed the patient to reset the communicator and assisted them in connecting it to their INS, but the screen became stuck on the "Connecting" screen again and it wont even connect. The agent then instructed the patient to reset both the handset and the communicator. After that, the patient attempted to connect to their Mystim app and was able to view the therapy screen. The patient stated that the therapy was on, but they could not feel the stimulation. The agent then instructed the patient to make adjustments in the settings and redirected them to their healthcare provider (HCP)  if further assistance was needed. Patient called back and repeated previously documented  information. Patient reported issue persisted with handset stuck on "Connecting screen" even after restarting both handset and communicator. Patient stated they could not continue living with the need to repeat connection steps every time they attempt

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50894783 ↗
• MalfunctionSep 24, 2026Battery Problem

  Information was received from a patient regarding an implantable neurostimulator (INS). The reason for call was caller reported seeing ERI Service Code 201 message on their handset since yesterday. Agent reviewed meaning of message. Caller stated they just got the implant in April and thought it would last for 3 years. The patient was redirected to their healthcare provider (HCP) to further address next steps.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886160 ↗
• InjurySep 24, 2026Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Data Problem

  Patient problems: Device Overstimulation of Tissue; Electric Shock; Pain

  MAUDE report 50885514 ↗
• InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation

  The reason for call was patient mentioned that they needed assistance turning the therapy off. Patient mentioned that whenever they would lay down, they would get electric impulses. Patient mentioned that they might need to have exams and might lay on their back, so Patient needed to turn the Therapy off. Agent had Patient connect to MyStim app and mentioned that they were not able to connect. Agent had Patient reset the communicator, and connect to MyStimPC. Agent walked Patient thru turning the Therapy off, Patient confirmed Therapy was off. Agent walked Patient through on how to enter into an MRI mode.

  Patient problems: Electric Shock

  MAUDE report 50883922 ↗
• InjurySep 23, 2026Energy Output Problem; Insufficient Device Problem Information

  Information was received from a patient's representative (caller) regarding an implantable neurostimulator (INS). Caller reported that the day the device was turned on, the patient was supposed to have an appointment, but they did the appointment over the phone because the patient's wife was in the ER. Caller stated they don't think the patient got properly trained and is now panicking that they cannot get the stimulation turned off and is stating this company is not helping them and no one will call them back. Caller stated the patient turned their stimulation on the day before yesterday and thought they turned it off last night; however, even though the MyStimPC app says therapy is off, patient reports they are still feeling the stimulation. Agent reviewed information, including possibility of residual stim, and caller agreed patient should have an appointment in person to review device general use as well as interrogate the implant, if needed. Agent reviewed role of rep as well as NAS and redirected to healthcare provider (HCP). Caller mentioned historical information that the patient had a car accident the day the device was turned on and they saw the patient in t he ER after t

  Patient problems: Anxiety; Inappropriate Device Stimulation of Tissue

  MAUDE report 50870171 ↗
• InjurySep 22, 2026Intermittent Continuity; Patient Device Interaction Problem

  Patient problems: Device Overstimulation of Tissue; Insufficient Information

  MAUDE report 50856178 ↗
• InjurySep 21, 2026Inappropriate/Inadequate Shock/Stimulation

  Information was received from a patient (pt) regarding an external device. The reason for call was Pt stated that they charged the handset and communicator fully, however they were seeing Communicator Not Found when trying to connect. Pt said that the handset asked for the communicator serial number, so they had scanned the barcode but the devices still wouldn't connect. Pt attempted to connect during the call and still saw Communicator Not Found. Pt saw that only the green light was lit up on the communicator. Agent guided the Pt through resetting the communicator. Agent then had the Pt attempt to connect. Pt noted seeing the blue light lit up on the communicator as well. Communication was then successful. The troubleshooting steps taken during the call resolved the issue. Pt noted that they wanted to decrease the stimulation intensity since they had a cold and they felt a zap every time they coughed.

  Patient problems: Electric Shock

  MAUDE report 50841182 ↗
• InjurySep 21, 2026Energy Output Problem

  It was reported that the patient with an implanted neurostimulator and leads experienced new sacroiliac-area pain unrelated to baseline pain, pain at the neurostimulator/battery site, and an abrasive sensation around the battery site. During reprogramming on (b)(6)2026, the patient reported leg heaviness, suspected high stimulation, and requested stimulation adjustment. The abrasive sensation had been present immediately before reprogramming. Device impedance testing was optimal, no signs of overstimulation were observed, and programming adjustments were made. The patient later reported that the leg heaviness was part of the pre-implant pain. The patient attempted to lower the device settings and subsequently turned the device off; normal baseline pain returned with the device off, while the new sacroiliac-area pain and abrasive battery-site sensation persisted. The patient contacted the healthcare provider on (b)(6)2026 regarding recurrent pain and abrasive sensation. On (b)(6)2026, the physician advised the patient to return for sacroiliac- area epidural injections and further evaluation of the operative/implant site, planned for (b)(6)2026. No rash, redness, oozing, or other iss

  Patient problems: Device Overstimulation of Tissue; Insufficient Information; Pain

  MAUDE report 50840537 ↗
• InjurySep 18, 2026Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation

  Information was received from a patient regarding an external device. The reason for call was patient reported they had been having trouble with their device ever since they were first implanted with their current implant. Patient said they were supposed to be having an MRI, but they could not get into the therapy app and communicator was not coming on. Agent asked, patient said they didn't know when they first got the issue, but the manufacturer representative (rep) told them that the device just kept going around in a circle and that's what it was doing now. Patient also said the communicator had an orange light on it and had been plugged in all night. Patient stated handset was circling on circling and connecting. Agent had patient plug communicator in to AC power supply and patient confirmed the light on communicator was solid green. Patient unplugged communicator from AC power and lights remained solid green. Patient reset communicator. Patient then attempted to connect to their therapy application, but reported communicator light was orange again. Patient plugged communicator back in and confirmed the green light came back on. Patient reset handset then reentered communicator

  Patient problems: Pain; Sleep Dysfunction

  MAUDE report 50820703 ↗
• MalfunctionSep 18, 2026High impedance; Positioning Problem

  Information was received from a healthcare professional (HCP) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (INS). It was reported that the lead was implanted and remained in service. There was no patient involved. During implant it was noticed that contact 2 showed damage. When physician connected lead to battery, connection and impedances were checked. Contact 2 showed connection issue and high impedance. Physician was made aware. Physician decided to close and move forward. Physician wiped leads clean. Lead was placed into INS and physician wrench to tighten lead. An additional connectivity check and impedance check were performed. Contact 2 showed connection issue and high impedance. Physician informed again. Physician decided to close and move forward. HCP's had difficulty getting lead into epidural space due to patient anatomy. Additional information was received from a manufacturer representative (rep). The rep reported that the outcome will be more clear at first post op appointment when an impedance check can be done to see if it's cleared. Patient was doing well in post op immediately following the procedure and was able to

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818398 ↗
• InjurySep 17, 2026High impedance; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Burning Sensation; Electric Shock

  MAUDE report 50807361 ↗
• InjurySep 17, 2026High impedance; Low impedance

  It was reported that a patient with an implantable neurostimulator system fell on the left buttock/hip a few days before the initial report and reported continued pain relief and a difference in normal pain. The patient reported discomfort, soreness, or pinching and was alive with no injury. A postoperative evaluation was performed, and stimulation thresholds were set for all groups. The patient was instructed to gradually adjust stimulation as needed for comfort. Impedance testing identified high impedance greater than 40,000 on contact 2. Contacts 4 and 13 were within normal limits but reflected a possible short; contacts 2, 4, and 13 were not used for programming. No changes were made other than setting stimulation thresholds. Imaging was not planned unless the patient developed increased pain. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Discomfort

  MAUDE report 50802828 ↗
• InjurySep 16, 2026Energy Output Problem; Data Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was pt stating they have groups A, B, and C for their therapy and each group has 2 programs on it. Pt stated when they connect, it was turning on programs in another group. Pt stated they turn on therapy for groups C and then they go back to group A and that has turned on. Agent reviewed information about switching groups/changing intensity up and down. Pt then stated it felt like it 'it is pretty hot' and 'a bit much'. Pt stated this issue just started 'lately' and all of the sudden. Pt stated they feel like they were getting multiple therapies. Pt denied falls/trauma. Pt stated the healthcare provider (HCP)  usually refers them to manufacturer to run diagnostics. Pt stated this issue has not happened in the past. Pt will follow up with HCP to further address their concerns about the groups.

  Patient problems: Burning Sensation; Device Overstimulation of Tissue; Insufficient Information

  MAUDE report 50790274 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was a potential nerve hit during implant. During the SCS implant, as the healthcare providers (HCP) were accessing the interlaminar space with the epidural toughie needle, the patient described sharp stinging going down her leg, intraoperatively. The patient reported new pain. There also seemed to be some sort of CSF or liquid coming back from the needle. Patient was moving on the table for a while before the needle was then removed and repositioned. The rest of the implant went smoothly with no issue. It was the needle placement that ultimately caused the patient's discomfort. Post operatively, patient was in a lot of pain saying she felt "burning and shooting pain down her right leg." Rep called her on (b)(6) 2026 to check on her, and she said the pain was starting to soothe down. However, today the HCP let reps know the patient called the clinic and reported her leg as being "dead weight with no sensation." Patient was told to go to the emergency room today, (b)(6) 2026. No other information was given. Potential disability for this patient as she described her right leg as "dead weight with no sensation." The rep later noted the patient was admitted to

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Discomfort; Fluid Discharge; Nerve Damage; Numbness; Pain

  MAUDE report 50776944 ↗
• InjuryAug 26, 2026Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area

  It was reported that the implanted SureScan MRI 2x8 paddle lead migrated from its original surgical placement. The patient reported return of pain and inadequate pain relief. Reprogramming was attempted but was unsuccessful. Imaging showed paddle lead migration. Loss of therapy, stimulation in an undesired location, and an unspecified other stimulation issue were reported. Updated imaging was performed, and follow-up was planned for the postoperative visit. A replacement product was requested. The issue was ongoing. The manufacturer representative (rep) indicated they would send any further information as they become aware. Additional information was received from the manufacturer representative (rep). It was reported that the patient met with the surgeon and surgical revision is planned.

  Patient problems: Pain

  MAUDE report 50456071 ↗
• InjuryAug 18, 2026Failure to Interrogate; Migration or Expulsion of Device; Energy Output Problem; Overheating of Device; Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was Patient reported experiencing a sensation of electrical shock and was unsure if it was related to the communicator charging issue. The patient attempted to connect to the MyStim application but received a "Not Found" error message. The patient retried the connection and reported being on Group B at 2.8 before switching to Group C with therapy turned on. Patient stated they could feel stimulation extending through their legs, buttocks, ankles, and feet. They reported that these sensations had been occurring for the past several months and were particularly noticeable when bending their knees. The patient described the stimulation intensity as overwhelming. Additionally, the patient expressed concern that the INS may have shifted from its original position, reporting a noticeable lump on their back accompanied by spinal pain and a burning sensation. The patient also stated that the discomfort had made walking difficult and questioned whether it was normal to experience electrical shock sensations radiating from the buttocks down the legs. Agent redirected the patient t

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Device Overstimulation of Tissue; Discomfort; Electric Shock; Pain

  MAUDE report 50305926 ↗
• InjuryJul 31, 2026Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Patient Device Interaction Problem

  Information was received from a patient regarding an implanted neurostimulator (INS). It was reported that they are not having any back pain and the only pain they are having is where the INS battery is located. Caller stated this has been going on since the implant procedure and they expected to have pain after the procedure but are still experiencing it. Caller reported that if they lean on their back it causes serious pain. Caller said even when they are not leaning on their back they get random little pains that come that are kind of sharp. Caller stated they were told this is normal but they don't think it is. Caller also reported that the INS is not really providing them any help anyway and are considering having it explanted. Caller said the managing healthcare provider (HCP) ordered an MRI because they think the leads may have moved and this may be why it is not helping with their pain at all. Caller reported that when they raise their hands in the air they feel the current going through their whole body and also feel this when they lie on their back. Caller expressed frustration regarding the active scan time limit for MRI. Caller said they were not aware of this prior to

  Patient problems: Inappropriate Device Stimulation of Tissue; Insufficient Information; Pain

  MAUDE report 50097530 ↗
• InjuryJul 30, 2026Failure to Deliver Energy

  It was reported that patient could not get the handset to connect to the communicator. The issue started about 3 days ago. Patient could not turn stim off at night or when they wanted to turn it off because it would not connect. Patient spoke with the representative last night for a good 30 minutes and they could not do anything with it to get it to connect. On the call instructed patient to reset the communicator and restart the handset. Instructed patient to close out of the app and try connecting again. Patient was able to successfully connect. The troubleshooting steps that were taken on the call resolved the issue. Reviewed best practice to close all and let TM91 go into sleep mode. Patient also reported they put this implantable neurostimulator (INS) last fall and one side worked and other side did not and patient had to have it redone. Patient also mentioned before patient could not do anything because the legs were hurting so bad. Now they were able to walk without a walker around the house.

  Patient problems: Pain

  MAUDE report 50088400 ↗
• InjuryJul 30, 2026Energy Output Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported they with with their representative the other day and the rep changed their Programs 1 and 4 on Group B and was told to leave Programs 2 and 3 alone. Patient was not supposed to mess with Programs 2 and 3 but last night patient turned the stimulation down because he stimulation went too high and they were shaking in bed. Patient inquired what stimulation setting the rep set their Programs 2 and 3 at. Patient was escalated. Agent redirected patient to their HCP to address the issue.

  Patient problems: Device Overstimulation of Tissue; Shaking/Tremors

  MAUDE report 50087448 ↗
• InjuryJul 29, 2026Battery Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was pt reported receiving the ERI message, service code 201, on the handset when connected to the MyStim app for about 7 days. Pt expressed confusion because implantation was recent and the message was already appearing. Agent redirected pt to the manufacturer representative (rep), and pt confirmed an appointment scheduled for tomorrow.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071699 ↗

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