Intellis™ AdaptiveStim® 97715 (UDI 00643169781702)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23,976 adverse event reports that list this exact device (DI 00643169781702), received between Oct 17, 2017 and Sep 30, 2026 — classified as 2 deaths, 5,893 injuries, 18,081 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (6,995 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 23,976 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Failure to Deliver Energy

  Patient problems: Pain

  MAUDE report 50953450 ↗
• InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock

  MAUDE report 50952255 ↗
• InjurySep 30, 2026Migration or Expulsion of Device

  Information was received from patient regarding an implantable neurostimulator (INS). The patient reported that the INS site was pai nful and expressed concern that the device may have shifted. The patient confirmed there have been no recent falls or trauma. The agent reviewed the information and referred the patient to their healthcare provider (HCP)  for further assistance.

  Patient problems: Pain

  MAUDE report 50949531 ↗
• InjurySep 30, 2026Noise, Audible

  Information was received from a manufacturer's representative regarding an implantable neurostimulator. The reason for call was Caller reported that on Saturday the patient heard a buzzing sound coming from their stimulator. Caller said the patient got out of their car after getting to a friend's house and the friend told the caller that the noise was coming from the patient's stimulator. The buzzing eventually stopped on its own. Caller stated the stimulator was 8 years old and that the patient knew how to use the device and it was working. Agent suggested patient monitor device to see if buzzing returns, and if it does to try turning therapy off to rule out implant as cause.

  Patient problems: Insufficient Information

  MAUDE report 50947786 ↗
• MalfunctionSep 30, 2026No Device Output

  Information was received from a patient regarding an implantable neurostimulator (INS). They stated they were supposed to undergo an MRI and had been told that their INS needed to be turned on, but they had been unable to turn on the device, which they found very upsetting. Pt stated that this issue had been ongoing for approximately 4 to 5 months. Agent had pt initiate an INS charging; pt confirmed that the INS was charging with excellent quality, controller was at 80% and INS was at 50%. Agent walked pt through activating the MRI mode. Agent reviewed that their devices were functioning as intended, instructed the pt to continue charging their INS and call MDT back if they need further assistance. PT called back stating her controller is now down to 70% and the INS went up to 60%. Agent advised to continue to charge as she was charging and to call back if she has further questions. Agent reviewed the controller will drain somewhat.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947526 ↗
• InjurySep 30, 2026Failure to Deliver Energy

  Information was received from a patient regarding an implantable neurostimulator. The reason for the call was patient reported that their stimulation turned off, and they do not know why. Patient stated they noticed the INS was off during this past weekend. Agent walked patient through checking their INS settings. Patient confirmed the therapy was OFF. Agent walked patient through turning the therapy back on. Patient confirmed the therapy was back on. Agent reviewed controller general use. Patient confirmed the controller battery was at 80%, and the INS was at 70% during the call. The steps done during the call resolved the issue. Agent also redirected patient to their HCP if they needed adjustments with their settings.

  Patient problems: Insufficient Information

  MAUDE report 50947028 ↗
• InjurySep 30, 2026Migration or Expulsion of Device

  Patient problems: Erosion

  MAUDE report 50945835 ↗
• InjurySep 30, 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 the INS and leads were explanted. Additional information was received from a manufacturer representative (rep). It was reported that the patient fell on a slip-and-slide during their 40th birthday part and that the system was bothering them after. It was unknown when the patient started experiencing this as they had not contacted local reps for reprogramming or system interrogation. The cause was stated to be the system hurting the patient after their fall. The issue has been resolved.

  Patient problems: Discomfort; Pain

  MAUDE report 50944822 ↗
• MalfunctionSep 30, 2026Overheating of Device; Charging Problem

  Information was received from patient's rep regarding an external device. The reason for call was caller reported that they need to put the implantable neurostimulator (INS) into MRI mode, but they could not charge it. Caller stated that the paddle was getting hot when recharging the INS. Agent reviewed the information and sent a request to repair to replace the recharger.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942624 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Burning Sensation; Pain

  MAUDE report 50937758 ↗
• MalfunctionSep 29, 2026Unauthorized Access to Computer System; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934873 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933419 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock; Pain

  MAUDE report 50933382 ↗
• InjurySep 29, 2026Break; Adverse Event Without Identified Device or Use Problem

  It was reported that a suspected infected pressure wound occurred at the implantable neurostimulator (INS) pocket site.  On (b)(6) 2026, the INS was partially explanted and the leads were cut. The wound was debrided and treated with vancomycin. The patient was sent to the emergency department following discovery of the infection. Referral to neurosurgery for paddle lead removal was planned for (b)(6) 2026; the status of the paddle lead removal, additional medication management, infection, and overall patient outcome were unknown. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pressure Sore/Ulcer; Unspecified Infection

  MAUDE report 50933370 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50926348 ↗
• InjurySep 28, 2026Failure to Deliver Energy

  Patient problems: Insufficient Information

  MAUDE report 50923580 ↗
• InjurySep 28, 2026Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  Patient problems: Electric Shock

  MAUDE report 50919895 ↗
• InjurySep 28, 2026Failure to Deliver Energy; Energy Output Problem

  Information was received from a patient regarding an implantable neurostimulator (INS). Patient called back reporting their device was still not working since their last call into Patient Services. Patient clarified they think the INS is charged, but they are not feeling stimulation. Patient reported controller at 60% and implant at 100% with therapy on in Group C. Patient changed to Group A and reported they still did not feel anything. Patient changed to Group C and reported feeling very intense stimulation that definitely was not comfortable. Patient changed back to Group A and reported they were still feeling the intense stimulation. Patient turned therapy off. Agent reviewed role of representative and provided phone number. The patient was redirected to their healthcare provider (HCP) to further address.

  Patient problems: Device Overstimulation of Tissue; Discomfort

  MAUDE report 50918074 ↗
• InjurySep 28, 2026Overheating of Device

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was Pt reported every once in a while, they get a 'burn' where the implant is located that will last for a minute then it will be gone and happened again 2 to 3 times over the next day or 2 and will not happen again for another month. Agent attempted to clarify the issue. Pt said they felt a burning sensation on the implant down below the waist and it hurts sometimes. Pt said the issue started about 6 months and in the last 3 months it was 'burning'. Agent had difficulty understanding the patient and tried to obtain pertinent details. Agent reviewed information and redirected pt to their HCP to further address the issue. Pt said they haven't been able to speak with their HCP since they got the implant. Agent reviewed contacting the field for visibility.

  Patient problems: Burning Sensation; Pain

  MAUDE report 50917595 ↗
• MalfunctionSep 28, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917376 ↗
• InjurySep 28, 2026Failure to Deliver Energy; Battery Problem; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50917120 ↗
• MalfunctionSep 25, 2026Migration or Expulsion of Device; Malposition of Device; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903704 ↗
• InjurySep 25, 2026Electromagnetic Interference; Energy Output Problem

  Information was received from a healthcare provider (HCP) regarding an implantable neurostimulator. The reason for call was caller states the patient has not used their device since July of last year because they had an MRI and the high setting was uncomfortable for them.  The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Device Overstimulation of Tissue; Discomfort

  MAUDE report 50900054 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  Information was received from a patient representative (caller) regarding a patient (pt) an implantable neurostimulator (INS). Caller confirmed implant was replaced with another manufacturer's device but the manufacturer lead was kept. Agent reviewed lead information to caller and warm-transferred caller to registration.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899314 ↗
• MalfunctionSep 25, 2026Energy Output Problem; Charging Problem; Insufficient Device Problem Information

  It was reported that for the past few weeks the patient(pt)'s implanted neurostimulator(INS) has not been working right. Patient stated that they have called several times and the last time they called they were on the phone for quite a while and they were told to call back the next day if it wasn't working because it was slightly working starting to work during the call. Pt stated they got busy and forgot to call back, but the issue had persisted since their last call to Patient Services (PSS). During the call the patient reset the controller and attempted to recharge their implant, the controller was not able to find the device. Pt confirmed the INS had some charge level. The issue was not resolved. A request was sent to the repair department to replace the Controller. Patient called back stating they received the replacement controller; however, were unable to complete the setup process. Patient reported screen displayed Connect the Recharger and confirmed recharger was currently connected. Agent had patient disconnect and reconnect the recharger; Connect the Recharger continued to display. Patient reset the controller, tapped Setup for Implant, and again reported Connect the Re

  Patient problems: Pain

  MAUDE report 50899107 ↗

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