Intellis™ AdaptiveStim® 97715 (UDI 00763000315467)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11,487 adverse event reports that list this exact device (DI 00763000315467), received between Apr 13, 2021 and Sep 30, 2026 — classified as 3,616 injuries, 7,871 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (2,400 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 11,487 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Failure to Deliver Energy; Failure to Interrogate; Energy Output Problem; Battery Problem; Communication or Transmission Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  Patient problems: Pain

  MAUDE report 50952544 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Data Problem

  Patient problems: Pain

  MAUDE report 50952108 ↗
• InjurySep 30, 2026Overheating of Device

  Patient problems: Burning Sensation

  MAUDE report 50951831 ↗
• MalfunctionSep 30, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950425 ↗
• InjurySep 30, 2026High impedance; Unintended Collision

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (INS). The rep stated the patient (pt) was explanted this morning due to high impedances and also due to the fact that the pt had a fall, all starting in (b)(6) 2026. The rep stated the healthcare provider (HCP) specified that there was potential for fracture of the leads. The leads and battery were removed and 2 new leads and a battery were placed.  **See PE#709415900 for split information regarding new implant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948332 ↗
• MalfunctionSep 30, 2026Migration or Expulsion of Device; Charging Problem

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (INS). Caller stated that the patient is experiencing difficulty with charging the implant because the battery itself feels like it has moved more in her flank. Caller stated the healthcare provider is wanting to do a battery replacement. The patient was redirected to their healthcare provider to further address the issue. Caller understands the INS has moved from flank area (original implant area) to her buttocks.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947653 ↗
• InjurySep 30, 2026Migration or Expulsion of Device; Unintended Collision

  Patient problems: Pain

  MAUDE report 50947582 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Unintended Collision

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was pt reported that yesterday, they were sitting on a rollator when the back wheel gave out causing them to fall onto their back and side. Pt mentioned could feel the stimulation really well on the right side of their body but don't really feel the stimulation at all on their left. Pt wanted the implant to be checked to see if everything was okay. Agent redirected the pt to the HCP and rep to further address but pt stated they moved and currently don't have a managing doctor.

  Patient problems: Insufficient Information

  MAUDE report 50947511 ↗
• InjurySep 30, 2026Migration or Expulsion of Device; Unintended Collision

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient stated they fell on their back where the implant is located. Patient said they believe they dislodged the implant because the area hurts. Patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Pain

  MAUDE report 50946576 ↗
• InjurySep 30, 2026Migration or Expulsion of Device

  Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (INS). Device registration submitted by the representative indicated that the patient's lead migrated and was replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945100 ↗
• InjurySep 30, 2026Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Information was received from multiple sources regarding a patient implanted with a neurostimulator (INS). Lead migration/dislodgement and inadequate pain relief was reported. It was reported that the SCS is not helpful and has been turned off. Met with a manufacture representative on 4/14/26 and was told that there were issues with their leads. unable to do lead revision due to AFIB and recent placement of pacemaker. Patient reported that as far as they know, the device is not working even if they charge it. It charges and functions but it doesn't provide the therapy they need. Patient has not had the device checked out by the HCP for a while and do not plan to deal with the device as they had other unrelated health issues that they need a surgery for; patient confirmed the surgery was unrelated. Patient was asked about the lead issues and patient said they just told them that leads were not working. Patient doesn¿t remember if there was a manufacturer rep present there or not. This was about a year ago. Patient said the HCP has always been the same as the one who implanted the device but patient doesn¿t remember the name. Patient said as far as they remember, no one mentioned lea

  Patient problems: Insufficient Information

  MAUDE report 50944782 ↗
• InjurySep 29, 2026Electromagnetic Interference

  Patient problems: Pain

  MAUDE report 50937587 ↗
• InjurySep 29, 2026High impedance; Unintended Collision

  Patient problems: Pain

  MAUDE report 50935091 ↗
• InjurySep 29, 2026Failure to Deliver Energy; Battery Problem

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Pain; Swelling/ Edema

  MAUDE report 50933385 ↗
• InjurySep 29, 2026Failure to Deliver Energy

  Patient problems: Insufficient Information; Pain

  MAUDE report 50932811 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Pain

  MAUDE report 50932561 ↗
• InjurySep 29, 2026Overheating of Device

  Information was received from a patient's representative regarding an external device. The reason for call was Patient reported that the recharger became warm during use and felt like it could burn them. Issue was first noticed last night. No visible damage was noted on the recharger cord; however, the patient reported a small burned area inside the recharger paddle. Due to the reported overheating and evidence of burn marks, the agent submitted a Request to Repair for replacement of the recharger.

  Patient problems: Burning Sensation

  MAUDE report 50930964 ↗
• InjurySep 28, 2026Impedance Problem; Insufficient Device Problem Information

  Patient problems: Pain; Sleep Dysfunction

  MAUDE report 50923445 ↗
• MalfunctionSep 28, 2026Battery Problem; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920529 ↗
• InjurySep 28, 2026Energy Output Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient said that they will turn stimulation off but will feel stimulation still and said "its just one of the 4 program channels and when I do turn it back on, I go to turn the setting down and it says I cant lower it any more - even though its at 5.4v". PT says if they turn stimulation off and then on again it will let them turn it down to zero. They said this originally started happening about a month ago. They said this seems to happen after they charge their implant. Pt said that last night they "started playing with their settings because it was doing weird stuff and they had to turn it off". The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Insufficient Information

  MAUDE report 50915879 ↗
• MalfunctionSep 28, 2026Battery Problem; Charging Problem

  Information was received from a patient's representative regarding an implantable neurostimulator. The reason for call was caller reported that for the past couple months, the patient stated that the implant battery dies very quickly and they have to recharge it every day. Agent reviewed implant battery depletion is dependent on settings and usage of the therapy. The patient was redirected to their healthcare provider to further address their concerns.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915444 ↗
• InjurySep 28, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Discomfort; Electric Shock; Pain; Sleep Dysfunction

  MAUDE report 50914273 ↗
• MalfunctionSep 28, 2026Overheating of Device; Delayed Charge Time

  Information was received from a manufacturer's representative regarding an external device. The reason for call was the caller reported that the recharger is getting hot during charging sessions and it takes 2 to 3 hours to charge the implanted neurostimulator (INS). The issue has been going on for a long time but it got very bad the last 2 months. Technical services (TSS) placed a request to send a replacement recharger to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911692 ↗
• InjurySep 25, 2026Failure to Deliver Energy; High impedance; Therapeutic or Diagnostic Output Failure

  Patient problems: Ambulation or Postural Difficulties; No Clinical Signs, Symptoms or Conditions; Pain; Sleep Dysfunction

  MAUDE report 50904130 ↗
• InjurySep 25, 2026Failure to Interrogate; Malposition of Device; Charging Problem; Communication or Transmission Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient reported that "at the end of last year the therapy started doing the opposite of its job and causing pain", they turned off the therapy. Patient needs an MRI with contrast "because something else is going on" with their left hip. Pt mentioned they're unable to charge the implant but confirmed they're able to charge the controller. Pt mentioned the implanted battery sticks out, when they tried to charge the implant it was getting excellent but won't stay connected. Agent reviewed passive recharge mode and was about to do troubleshooting. Pt then mentioned they might need to charge the controller first. During the call, pt mentioned that they called before and the last time they saw a manufacturing representative (rep) was 2 years ago, see (b)(4).

  Patient problems: Insufficient Information; Pain

  MAUDE report 50899895 ↗

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