Intellis™ 97716 (UDI 00763000315474)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,125 adverse event reports that list this exact device (DI 00763000315474), received between Jun 4, 2021 and Sep 28, 2026 — classified as 363 injuries, 762 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (229 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 1,125 reports, 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 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 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 ↗
• InjurySep 18, 2026Failure to Deliver Energy; High impedance; Low impedance; Patient Device Interaction Problem

  It was reported that, following an incident unrelated to the implanted Intellis Pain neurostimulator in which the patient almost fell while exiting the shower but caught themself, the patient no longer felt stimulation and experienced return of pain and loss of pain relief. A low impedance or short issue was reported. Connection check showed red X indicators on electrodes 4, 5, 6, 7, 9, 12, and 13 and values greater than 40,000 with a possible open short involving lead electrodes 0 through 7 during a full in-pain check. The neurostimulator was reprogrammed. The issue was reported as resolved. The patient was alive with no injury. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Pain

  MAUDE report 50819013 ↗
• InjurySep 17, 2026Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  Patient problems: Electric Shock

  MAUDE report 50809844 ↗
• InjurySep 16, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796818 ↗
• InjurySep 9, 2026Failure to Deliver Energy; Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  Patient problems: Insufficient Information

  MAUDE report 50699676 ↗
• InjurySep 1, 2026Therapy Delivered to Incorrect Body Area

  It was reported that a patient noted that when stimulation was increased to obtain lower-extremity relief, intense stimulation or buzzing in the ribs was reported with all programs. Reprogramming was performed using both implanted leads, and rib stimulation continued. Some lower-extremity relief was reported when stimulation was maintained at a low level sufficient to avoid rib stimulation. An impedance check was performed, and all contacts were within normal limits. Thoracic-spine imaging was ordered, and follow-up was planned after imaging was completed. The stimulation-related rib sensation remained ongoing. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50546676 ↗
• InjuryAug 24, 2026Insufficient Device Problem Information

  It was reported that the implanted Intellis implantable neurostimulator had stopped working approximately 8 weeks earlier and was no longer helping with pain or providing sufficient pain coverage. The patient reported no falls or accidents that would have affected the device. Lead connections and impedances were checked and were within normal limits. The battery was replaced, and the device was explanted. No evidence that anything was wrong with the device was identified. The issue was 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: Pain

  MAUDE report 50407618 ↗
• InjuryAug 20, 2026Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Insufficient Device Problem Information

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for the call was patient stated as of recently, the INS was not helping as they thought it would to treat their lower back. Patient stated they were not happy with the device. Patient stated they would always feel a zapping constantly from their lower back to their toes, and that's how they knew the device was not working (INS depleted) due to the zapping stopping. Patient stated they used to charge every 3 days, but they met with a representative who changed all their programs, and now they charge every 7-10 days. Patient stated both their flanks still hurt. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Electric Shock; Pain

  MAUDE report 50350975 ↗
• MalfunctionAug 17, 2026Charging Problem

  Information was received from a patient (pt) regarding an external device. The reason for call was patient reported that they noticed 2-3 weeks ago they've been getting "battery needs to be replaced soon" message every time they charge the implant; pt added that they're also experiencing longer charging time and needing to charge the implant more often. Agent attempted to troubleshoot the device and get serial numbers; pt mentioned there's no visible damage with the controller and battery pack but was unable to read the serial number. Agent reviewed the need to troubleshoot the devices. Pt mentioned they will callback once their wife is at home. When asked about healthcare provider (HCP); pt can't remember the name but mentioned Spine and Joint Clinic. Patient and patient rep called back and repeated previously documented information. Patient requested a replacement battery pack for the controller after receiving a "Replace the controller batteries soon" message for at least the past three weeks. Patient was unsure whether the message appeared with or without the recharger. Patient stated the implant used to charge quickly, but they now had to charge it every day and for longer per

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50269815 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported they had to have their device removed because they ended up getting bacteria in their back after the surgery. Patient said the back pain they had was right where the stimulator was. Patient also said when they went in to remove the bacteria, there was a lot on the battery and the lead wires. Patient did not know when the issue started.

  Patient problems: Bacterial Infection

  MAUDE report 50145257 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implanted Intellis Pain implantable neurostimulator and an implanted MRI lead were removed after the patient reported a return of pain and stated that the system never really worked well for pain relief and that pain felt unchanged compared to the pre-implant baseline. The spinal cord stimulation system was explanted at the patient¿s request due to lack of perceived pain relief. The patient was reported to be alive with no injury, and the issue was reported as resolved. No patient complications have been reported as a result of this event. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Pain

  MAUDE report 50141746 ↗
• InjuryJul 30, 2026High impedance; Insufficient Device Problem Information

  It was reported that a Vectris MRICS Compact Lead 977A260 had high impedance identified on electrodes 8¿15 during the day of surgery, with impedance values reported as greater than 10,000. The patient had a history of many falls as reported by the patient. Impedances were tested with the patient standing, sitting, and lying. A physician planned to replace the lead due to the high impedance, and the product was explanted. The patient was reported alive with no injury. No patient complications have been reported as a result of this event. 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 50086087 ↗
• InjuryJul 29, 2026Failure to Deliver Energy; High impedance

  It was reported that an implanted Implantable Neurostimulator had high impedance on electrodes 9, 11, and 15, with impedance values noted as above 40,000, and there was a loss of stimulation. The high impedance was not observed on the day of surgery. Troubleshooting was performed by reprogramming around the affected electrodes. The issue was reported as resolved, and the patient was alive with no injury. No cause was known. No patient complications have been reported as a result of this event. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Insufficient Information

  MAUDE report 50068405 ↗

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