Intellis™ Pro 977118 (UDI 00763000984656)Recalls & reported problems

Summary

The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 00763000984656), received between Aug 19, 2025 and Sep 30, 2026 — classified as 72 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (33 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 201 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 50951705 ↗
• MalfunctionSep 30, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient said that their "leads slid down my spinal cord" and said this was found during their follow up appointment, and had an x-ray done to confirm this. They said they were given 3 programs to try and none of them seem to be working. They said they currently have an appointment with a healthcare professional and would like a representative to be there. Emailed local representatives asking them to call the patient back.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949034 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock

  MAUDE report 50934849 ↗
• InjurySep 28, 2026Migration or Expulsion of Device; Unintended Collision

  It was reported that the patient with an implanted LEAD 977A260 5MM COMPACT 1X8 experienced a recent fall, return of pain, and new pain unrelated to baseline. The physician expressed concern for possible lead migration or dislodgement following the fall, with concerns regarding pain coverage. The patient and provider requested reprogramming and lead assessment. X-ray imaging and evaluation by the physician were scheduled to assess lead impedances, programming, and pain coverage. The issue remained ongoing. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Pain

  MAUDE report 50916294 ↗
• InjurySep 28, 2026Failure to Deliver Energy; Therapy Delivered to Incorrect Body Area

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50915997 ↗
• InjurySep 25, 2026Intermittent Continuity; Failure to Deliver Energy; Insufficient Device Problem Information

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient stated their stimulator was not working and they were hurting very bad since about Wednesday last week. Patient's son then came on and confirmed stimulation was on and they had already tried changing stimulation. Caller said when the representative set up the programming, stimulation worked and stayed on and patient could slightly feel stimulation all the time. However, now after 10-20 minutes, the stimulation would shut itself off and they would have to go back to the handset and on the screen would turn the stimulation off and back on. Caller mentioned they had tried adjusting and changing programs already, but program 1 didn't do the patient any good anymore (even though it used to) and program 2 seems like it does ok, but also seems like stimulation would only stay on for like 10-20 minutes and then would shut off. The issue was not resolved. The patient was redirected to their healthcare provider to further address the iss ue.

  Patient problems: Pain

  MAUDE report 50898873 ↗
• InjurySep 24, 2026Energy Output Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported they hadn't had their stimulator working for a while and this was their first time calling. Patient stated the stimulator buzz in their back was not working. Patient said they had it all charged and it should be working from the screen they were looking at, but it just didn't. Agent asked if patient was not feeling like they were getting adequate pain relief in their body and patient said they were not getting any pain relief from the stimulator. When asked for the Event Date, patient stated it had been about a month or so. Patient confirmed therapy was on. The patient was redirected to their healthcare provider to further address the issue. Patient mentioned they had an appointment with their doctor today.

  Patient problems: Pain

  MAUDE report 50886064 ↗
• InjurySep 24, 2026Display or Visual Feedback Problem; Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable neurostimulator. The reason for call was patient reported it seemed as though the stimulator wasn't working like it used to as their right side was hurting and they were in so much pain. Patient called their doctor's office and was told to call manufacturer to "increase the voltage." Agent had patient connect through the MyStimRC app, patient reported therapy was on in Group A. Agent reviewed therapy information and general programming guidance in regards to changing groups and adjusting intensity. PT stated that in the morning she felt a strong electrical sensation and it was too high and needed help. Pt stated now they were seeing reboot system now and could not bypass the code. Agent attempted to walk pt through restarting handset. Pt was able to restart and get into the therapy settings to lower the stim. Pt stated it was working like it should now. Agent advised to call back if she needs more help. PT mentioned she was in so much pain.

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

  MAUDE report 50885029 ↗
• InjurySep 23, 2026Overheating of Device; Charging Problem

  Caller reports she was informed that her INS would last 1.5 days between charging, but she is needing to charge more frequently. Caller reports she would charge to 100% at night, the next morning, she needs to charge again. Caller reports she was informed never to let her INS battery level go below 40% Caller reports she has increased her stimulation. Redirect caller to patient's HCP. Caller reports whenever she charges her implant, the first 20 minutes of charging, she feels warm and itching. Caller reports she has her sterile strips on currently, almost falls off. Caller reports sometimes she can stay the warm/itching and sometimes she has to stop and take a break. Caller reports she is using a thin material between charging Redirect caller to patient's HCP

  Patient problems: Burning Sensation; Itching Sensation

  MAUDE report 50867695 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a manufacturer representative (rep) regarding a patient (pt) who was implanted with an implantable neu rostimulator (INS). It was reported that there was a device site infection. The patient was present at the doctor's office with fluid leakage from the battery pocket site when recharging and the doctor said it was likely a superficial infection and prescribed anti biotics. The patient was asked to turn off stimulation to avoid recharging over the area. The patient went to the emergency room due to increased pain ad was told by the attending that there was an infection. The patient was transferred to a hospital with an explant pending, but the date is not available yet. The rep stated that IV antibiotics were given to the patient but was unsure of what kind.

  Patient problems: Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 50867434 ↗
• MalfunctionSep 23, 2026Therapy Delivered to Incorrect Body Area; Battery Problem; Insufficient Device Problem Information

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported they can feel the stimulation in their arms but not their neck and in their legs but not their lower back. Patient stated if they turn the stimulation up they can feel it in their neck and back, but then it is tingling in their arms and legs so much they can't move them and they have to decrease it back down to where they're not feeling it where they want to. Patient stated they went back to the doctor today to get the device programmed, but they do not remember if they were on group A, B, or C. Patient mentioned they could feel the stimulation in their back really good and a little bit in their legs and sort of up their neck and a little in their arms, but now they feel it in their arms and legs not their neck or lower back. Agent reviewed therapy information as well as role of rep and redirected patient to their healthcare provider to further address. Patient reported handset was not charging and seemed to indicate the cord was loose in the port, although agent could not confirm this. Patient reported using dual adapter and, even with handset cord individuall

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inappropriate Device Stimulation of Tissue; Insufficient Information; Itching Sensation; Paresthesia; Swelling/ Edema

  MAUDE report 50865290 ↗
• InjurySep 22, 2026Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  Patient reported their therapy was not working properly. Patient described that they can be just laying in bed and when they cough or turn a little bit to the side they get a shocking sensation. Patient noted this occurred last night and it shocked them half to death, which agent understood as a figure of speech. Agent asked event date and patient stated it did this a little in the beginning and their manufacturing representative (rep) told them they just needed to find their groove and then it started again recently. Agent reviewed role of rep and provided NAS number. The patient was redirected to their healthcare provider (HCP) to further address the issue.

  Patient problems: Device Overstimulation of Tissue; Electric Shock

  MAUDE report 50853232 ↗
• InjurySep 22, 2026Failure to Deliver Energy; Energy Output Problem

  Information was received from patient (pt) regarding an implantable neurostimulator (INS) It was reported that their handset was showing 50% and the implantable neurostimulator (INS) will be dead. Patient explained their issue vaguely. Patient stated that the INS will stop giving stimulation when it was at 50%. Patient said that that did not happen often but periodically. Patient tried connecting to MyStim app and saw INS at 70% and Communicator at 10%. The patient then tried charging the INS and was able to charge fine. Patient added that they slept and woke up it was at 30%. Patient mentioned that they had an appointment with their healthcare provider (HCP) and manufacturer representative (rep) because they cannot go above 12 on the intensity. Patient stated that they watch their device, and they saw that the stimulation goes off at 50% battery level. When asked if it's handset charge, they did not respond. Agent reviewed information and redirected to HCP to further address the concern.

  Patient problems: Insufficient Information

  MAUDE report 50852934 ↗
• MalfunctionSep 21, 2026Battery Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient reported their implant would suck down fast or drain fast and the issue began probably a week ago. Patient had been waiting 3 or 3.5 months to get an MRI and was told by the MRI technician that the implant had to be 100% charged. Agent reviewed with patient to bring all their equipment and cords to the appointment just in case. Patient's implant was at 25% yesterday and was at 0 today. Patient was currently charging their implant during the call and was at 60%. Agent redirected patient to their HCP to address the issue.  See General Text for Omitted information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841112 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 50820723 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Intellis Pro implantable neurostimulator was associated with a device site infection involving the incision/pocket area. The patient was treated with antibiotics, and the implantable neurostimulator was explanted. The issue was resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Unspecified Infection

  MAUDE report 50817917 ↗
• InjurySep 17, 2026Failure to Interrogate; Migration or Expulsion of Device; Energy Output Problem; Communication or Transmission Problem

  Patient problems: Device Overstimulation of Tissue; Insufficient Information

  MAUDE report 50808827 ↗
• InjurySep 17, 2026Intermittent Continuity; High impedance

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator. The rep reported that the patient (pt) had an older lead and extension since 2008 and since the pt's battery replacement in (b)(6) 2026. Then, rep noticed the pt had all elevated impedances on the cervical lead, the 3778 lead, and the healthcare provider (HCP) decided to surgically replace the lead in (b)(6) 2026. When the healthcare provider (HCP) tested the lead inter-op, the lead impedances were fine and came back within range, so lead was never replaced. Pt complained of a lack of coverage, so rep had been reprogramming patient. Now, however, pt had adequate coverage, but pt said they had been getting "spikes in stimulation" that were annoying and not consistent based on position or the group the pt was in. Pt would be sitting and the stimulation would ramp up to a high level where it got uncomfortable and then go back down. Pt said the spikes were random and not associated with a certain position and happened in several positions randomly. The rep checked impedances on both leads and said the impedance values were fine, but one of the impedances was a little high on th

  Patient problems: Discomfort

  MAUDE report 50805305 ↗
• InjurySep 17, 2026Energy Output Problem; Therapy Delivered to Incorrect Body Area; Adverse Event Without Identified Device or Use Problem

  Information was received from a patient (pt) regarding an external device. The reason for call was Patient called in needing help to connect to the MyStim app and asked how to turn on and adjust therapy since they had not used it for a while. Patient stated they were in significant pain and needed to access the therapy app immediately. Agent assisted patient to connect to the MyStim app, but patient stated they could not find the communicator. Patient added they had been looking for it in the case but could not locate it and did not remember where they had placed it. Agent sent a request to repair to replace Communicator. Patient(pt) called back and confirmed they received the replacement communicator. Patient stated that they need help in using the device. Patient stated that this is the 1st time they try to use the device since implant. Patient initially have all the Interstim equipment available. Agent had the patient connect to MyStimapp but keep getting not found and no response even after selecting switch communicator. Patient tried charging INS and was able to confirm good connection and INS in red. Patient will continue charging INS first and will call back to asked assista

  Patient problems: Device Overstimulation of Tissue; Inappropriate Device Stimulation of Tissue; Pain; Shaking/Tremors

  MAUDE report 50799476 ↗
• InjurySep 16, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  Information was received from a patient regarding an implantable neurostimulator (INS). The reason for call was patient reported after having an MRI about 3 weeks ago, they feel like there is something going on with the stimulator and they feel some electrical charge. Patient asked if it is possible to reload the stimulator. Patient asked if they can turn down the stimulation. Agent offered to assist patient with using the external device and patient said they thought agent could work on their implant remotely. Agent reviewed device function and the call was dropped. Agent had difficulty understanding patient clearly. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Electric Shock

  MAUDE report 50794828 ↗
• InjurySep 16, 2026Charging Problem; Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was pt reported experiencing pain which started about 10 days ago and had gotten worse for the last 5 days. They requested to have a manufacturer representative (rep) be present on their upcoming doctor's appointment. Pt mentioned that they've been in contact with their local rep over the weekend and the rep told them that they would contact another representative to meet them as they were not available. Agent reviewed the role of the rep and the national answering service number. The patient was redirected to their healthcare provider to further address the issue. Additional information was received from a manufacturer representative (rep). It was reported that the patient had a return of pain. The issue was not resolved and there were no actions taken to resolve the issue. The patient states that since their replacement, they are not getting relief even though exact programming that was previously working was programmed. The patient states the device is defective. Troubleshooting with the patient with programs continues and the rep encouraged them to utilize all progra

  Patient problems: Pain

  MAUDE report 50786787 ↗
• InjurySep 15, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was last week Friday September 4th they had an MRI and before that PTs manufacturer representative (rep) gave them explicit instructions on how to enter MRI mode so they did. At the appointment the MRI tech was next to them and verified it was in MRI mode and about halfway through the MRI PT began getting little bits and shocks at the sight of the INS. PT did not push the button to stop the MRI because they did not want start over. PT was told the MRI would only be 15 minutes but it was longer than that. When PT got home they were sore and tender at the INS battery sight. When they looked in the mirror they say that on top of the battery their skin was red and extremely tender to the touch. PT applied first aid cream but it still looked the same. The mark was about two inches long and 3/8 of an inch wide as it followed the line of the top of the battery. PTs rep said they had never heard of that before and urged PT to call pati ent services. PT was still putting a cream on it but it had not changed in size of color. PT was afraid to have another MRI. PT wanted to know wh

  Patient problems: Discomfort; Electric Shock; Erythema

  MAUDE report 50775740 ↗
• MalfunctionSep 15, 2026Battery Problem; Charging Problem; Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was pt reported in 1 day their INS battery was completely discharged. Pt said they were charging now and they just charged 2 days ago and now it needs to be charged again. Agent reviewed information that the INS battery duration depends on their therapy settings as the higher the stimulation the more battery power it will used. Pt said it was not close to what they were told. Pt said if they should have known they had never done it. Pt said they had requested for a non-rechargeable battery to be put in them, so they don't need to worry about it. Pt said they were not happy and they will call their representative to get to the bottom of this. Agent documented reported event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50773581 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 50763356 ↗
• InjurySep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758012 ↗

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