Intellis AdaptiveStimRecalls & reported problems across all models
Medtronic, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 35,469
- Deaths reported
- 2
- Injuries reported
- 9,513
- Recalls
- 0
We found 3 models of Intellis AdaptiveStim by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 35,469 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2017 and Sep 30, 2026 — classified as 2 deaths, 9,513 injuries, 25,954 malfunctions.
The most frequently reported specific device problem is “Charging Problem” (9,397 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
Reports received per month, all models
Most reported Intellis AdaptiveStim problems
Device problems
- Charging Problem9,397
- Overheating of Device8,697
- Insufficient Device Problem Information7,253
- Battery Problem5,705
- Communication or Transmission Problem5,038
- Adverse Event Without Identified Device or Use Problem4,386
- Failure to Deliver Energy4,090
- High impedance4,010
Patient problems
- No Clinical Signs, Symptoms or Conditions16,253
- Pain8,372
- Insufficient Information3,286
- Burning Sensation2,707
- Electric Shock2,546
- No Known Impact Or Consequence To Patient2,519
- Therapeutic Effects, Unexpected2,333
- Discomfort1,723
Intellis AdaptiveStim models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Intellis™ AdaptiveStim® 97715STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- Intellis™ AdaptiveStim® 97715STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Intellis™ AdaptiveStim™ 97715Stimulator, spinal-cord, totally implanted for pain relief6 reports
Recent Intellis AdaptiveStim adverse event reports
The 15 most recent reports across all models, 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, 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, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Electric Shock
MAUDE report 50952255 ↗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, 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, 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 ↗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, 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 ↗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; 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, 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; 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 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
- Medtronic Azure Pacemaker12 models · 16,566 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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