Intellis ProRecalls & reported problems across all models

We found 2 models of Intellis Pro by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 498 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2025 and Sep 30, 2026 — classified as 1 death, 165 injuries, 332 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (86 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Intellis Pro problems

Intellis Pro models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Intellis™ Pro 977118

  Stimulator, spinal-cord, totally implanted for pain relief
  1 death297 reports
• Intellis™ Pro 977118

  Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
  201 reports

Recent Intellis Pro adverse event reports

The 15 most recent reports across all models, 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 30, 2026Electromagnetic Compatibility Problem

  Patient problems: Burning Sensation

  MAUDE report 50947523 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock

  MAUDE report 50934849 ↗
• InjurySep 28, 2026Failure to Interrogate; Delayed Charge Time; Malposition of Device; Charging Problem; Communication or Transmission Problem

  Information was received from a manufacturer's representative regarding an external device. The reason for call was representative said the patient has had some trouble charging their implanted neurostimulator. Representative said when they connected the wireless recharger to the patient's implant, they saw a screen that said to hold it there for 20 minutes. Representative also said about 5 minutes in, the screen switched to the normal charging screen where it gives you the percentage and tells you excellent or good. Representative asked if there was something they were doing wrong or if it was normal. Agent asked representative if the patient uses the belt when they charges and representative said they do. The representative also mentioned that the patient went to charge the device the other day and it took about 1.6 hours to charge from 40% to 100%, but the patient saw the same screen when they went to put it on and it still had charge in it. They typically are able to recharge within a "normal" amount of time. Manufacturing representative (rep) states the implantable neurostimulator (INS) is superficial, but there is some "puffiness" and the patient told her that it actually see

  Patient problems: Insufficient Information

  MAUDE report 50916874 ↗
• 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 ↗
• MalfunctionSep 28, 2026Delayed Charge Time; Charging Problem

  Information was received from a patient's (pt) representative regarding an implantable neurostimulator. The reason for call was Caller reported that for a while, the patient has been having issues with recharging the implant. Caller stated that it has been taking 3 hours plus to charge the implant and it only got to 60%. Caller stated sometimes pt gets good condition and sometimes excellent. Patient was not on the line and caller did not have the recharger with them at the time of the call. Agent asked caller if patient has had any falls or trauma and caller stated no, patient is in bed most of the time. Caller stated that the rep said the charger may be 'going bad' and we would be the ones to replace it. Pt rep will call back when they are available to troubleshoot with external devices.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915454 ↗
• 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, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare provider (HCP) reported that the patient had an infection with their spinal cord stimulator that led to the patient having the spinal cord stimulator explanted about 3 weeks after implant date.

  Patient problems: Unspecified Infection

  MAUDE report 50855320 ↗

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