IntellisRecalls & reported problems across all models

We found 3 models of Intellis by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,761 adverse event reports in the FDA's MAUDE database, received between Mar 27, 2019 and Sep 28, 2026 — classified as 554 injuries, 1,207 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (404 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 problems

Intellis models

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

• Intellis™ 97716

  Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
  1,125 reports
• Intellis™ 97716

  Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
  635 reports
• Intellis 97755

  Stimulator, spinal-cord, totally implanted for pain relief
  1 report

Recent Intellis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926354 ↗
• InjurySep 28, 2026Intermittent Continuity; Unintended Collision; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Charging Problem

  Patient problems: Device Overstimulation of Tissue; Electric Shock

  MAUDE report 50917320 ↗
• MalfunctionSep 28, 2026Impedance Problem

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator. The reason for call was rep states the patient had impedances on 0 and 1, which were "out" or red.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913698 ↗
• InjurySep 25, 2026Unauthorized Access to Computer System; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50904886 ↗
• InjurySep 25, 2026Failure to Deliver Energy

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient reported that since they had the implant put it the therapy "never worked", the stimulation "doesn't reach the area that it needed to hit". Pt mentioned they stop using since then, but now needed an MRI and they were trying to charge the implant but unable to charge it. Controller did not power on when the controller was removed from a/c cord. Pt asked for a manufacturer representative (rep) to help them with the device and the settings. Agent offered troubleshooting the device, tried to explain passive recharge mode to pt. Pt preferred an actual assistance of a Rep and stated they're "not savvy with technology and stuff". Agent reviewed HCP and Rep roles and redirected pt to healthcare provider(HCP) in reaching out to the Rep. Pt called back stating that they had called earlier as the INS never worked and the stimulation never hit the spot that the therapy was supposed to for their pain. Pt stated that the external equipment hadn't been used for a long time and they now need a MRI, so they need to charge their INS. Pt said that they were calling to coordinat

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

  MAUDE report 50896734 ↗
• InjurySep 24, 2026Migration or Expulsion of Device

  Patient problems: Discomfort; Pain

  MAUDE report 50890346 ↗
• InjurySep 24, 2026Failure to Deliver Energy; High impedance; Therapeutic or Diagnostic Output Failure

  It was reported that high impedances and loss of stimulation were reported. High impedance was not observed on the day of surgery, greater than 33, 000. The patient reported ongoing spinal cord stimulator performance problems and a message stating, ¿cannot provide desired intensity settings.¿  Following assistance, the system functioned for most of the day; however, the issue recurred after the system was powered off overnight. No troubleshooting was performed. The patient was redirected to their healthcare provider for further evaluation. The issue remained ongoing and unresolved, and the patient had no injury. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Insufficient Information

  MAUDE report 50883332 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was Patient reported they had the implant removed on (b)(6) 2026 because it had not been working for them. Patient added the implant had never worked well despite multiple attempts to adjust therapy and stated they had never felt the therapy was effective.

  Patient problems: Insufficient Information

  MAUDE report 50882632 ↗
• InjurySep 23, 2026High impedance; Therapeutic or Diagnostic Output Failure

  It was reported that a patient treated with an implanted Intellis pain neurostimulator system and two implanted MRI-compatible leads for pain management experienced return of pain and inadequate pain relief while stimulation was on. The system had not been used for over one year before it was restarted, after which high impedance and out-of-range error messages were displayed on the handset. High impedance was not observed on the day of surgery, greater than 40,000. The patient reported no falls, slips, or trips and reported no injuries from a motor vehicle accident. Stimulation was turned off, and the healthcare provider was notified. The product issue remained ongoing. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Pain

  MAUDE report 50869686 ↗
• InjurySep 23, 2026Insufficient Device Problem Information

  Information was received from a healthcare professional (HCP) regarding an implantable neurostimulator. The reason for call was caller stated that the patient's (pt) stimulator has not been on and/or functional for 2 years. The caller stated the pt was now working with an HCP who intended to remove the device but was seeking an MRI first.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868874 ↗
• InjurySep 22, 2026Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported that for about the past 6 months maybe they have been getting electric shocks on their right leg many times a day. Patient stated that sometimes they are just moving, changing their position on the couch or laying down and they get a shock down their right leg from their hip down to their toe. Patient said that it happens more frequently now than previously (it used to happen once per day or every once and awhile) and now happens many times per day. Agent asked the patient if they had any falls or trauma around the time the issue started and the patient stated no.Patient mentioned that they have had a lot of hardware installed in their back including a cage, 4 rods, 5 discs, 5 fusions, 3 in their neck and 4 in their back, and 15 screws. Patient also mentioned that there is a little protrusion coming out right in the middle of their back. Patient saw their surgeon and the surgeon said it might be some hardware that they put in there and if it's not bothering them then they don't need to do anything about it.  Patient said that the surgeon also said that if they

  Patient problems: Discomfort; Electric Shock

  MAUDE report 50858443 ↗
• InjurySep 21, 2026Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  Information was received from Patient (pt) regarding an external device. The reason for call was patient (Pt) reported their controller was not working right, stating that it turned on but displayed a message and was described as ¿the power was no good.¿ Pt stated their implant battery would not advance past 70% and confirmed that the controller battery was at 100%, while the implant remained at 70% all day. Pt also stated they attempted to charge their implant, but there was no progress. Pt stated spending 1 to 1.5 hours trying to figure it out and attempting to do so all morning. Pt mentioned previous calls. The pt expressed frustration, described the experience as horrible, and stated they had never had this much of a problem. Agent had pt reset the controller and blow air into the controller charging port. Pt confirmed no visible damage to the Controller and battery pack. Agent called the pt back due to a poor connection but the pt hung up. Patient called back stated they were very frustrated because they cannot get the INS to charge past 70-80% for couple weeks. Patient stated without the therapy they were in pain and they want to make sure the therapy was working and charging

  Patient problems: Distress; Insufficient Information; Pain

  MAUDE report 50841580 ↗
• InjurySep 18, 2026Failure to Deliver Energy; Data Problem

  Patient problems: Insufficient Information

  MAUDE report 50822139 ↗
• InjurySep 18, 2026Energy Output Problem

  Patient problems: Ambulation or Postural Difficulties; Device Overstimulation of Tissue; Pain

  MAUDE report 50820714 ↗
• InjurySep 18, 2026Failure to Deliver Energy; Charging Problem; Communication or Transmission Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  The reason for call was patient stated the spinal cord stimulator is not working. Patient said something about the internal battery needs to be replaced is what she sees. Agent asked when this started and patient said today and clarified a week ago. Patient then said it has been going off and stuff all the week this last week but now it is not work at all today. Agent walked patient through removing the battery pack and plugging controller into the AC power cord; Patient confirmed controller powers on. Patient inserted the battery and confirmed controller is 100% and implant is 70%. Patient then connected recharger and confirmed charging excellent. Patient tried to turn stimulation on and was getting poor quality. Patient turned stimulation back on but said they are not feeling anything in their body. Pt states shes been seeing settings not available in each group she tries. PT states just saw this Monday. Agent reviewed code and stated this has to do with the ins and not equipment. Agent reviewed options to try over phone however directed to hcp to check INS and the settings not available. The issue was not resolved through troubleshooting. The patient was redirected to their heal

  Patient problems: Insufficient Information

  MAUDE report 50820070 ↗

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