Intellis™ AdaptiveStim™ 97715Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000849047), received between May 7, 2025 and Jul 13, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2026Failure to Interrogate; Overheating of Device; Communication or Transmission Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804800 ↗
• InjuryDec 11, 2025Failure to Interrogate; Energy Output Problem; Charging Problem; Communication or Transmission Problem; Therapeutic or Diagnostic Output Failure; Failure to Interrogate; Energy Output Problem; Charging Problem; Communication or Transmission Problem; Therapeutic or Diagnostic Output Failure

  CALLER REPORTS PATIENT CANNOT INCREASE OR DECREASE IS SETTING. PATIENT CAME ONLINE, PATIENT INDICATED HE HAS BEEN SEEING AN ERROR MESSAGE: SETTING NOT AVAILABLE. CANNOT PROVIDE YOUR DESIRED INTENSITY SETTINGS SINCE (B)(6) 2025. PATIENT INDICATED HE NOTIFIED MANUFACTURER REPRESENTATIVE (REP) SINCE THEN. PATIENT ALSO INDICATED HE IS HAVING A HARD TIME CONNECTING AND CHARGING HIS IMPLANT. INS CURRENTLY AT 30% CHARGE. PATIENT DID NOT BRING HIS CHARGING EQUIPMENT FOR FURTHER TROUBLESHOOTING. SUGGEST PATIENT CALL TO PS FOR FURTHER TROUBLESHOOTING ON CHARGING. CALLER REPORTS PATIENT USING THE FOLLOWING ELECTRODES. ELECTRODE IMPEDANCE PERFORMED: GROUP A: PROGRAM 1. ELECTRODES: 3+5- : 2170 OHMS PROGRAM 2. ELECTRODES: 9/10: 1680 OHMS PROGRAM 3. 10, 11, 12, 13, 14, 15 REFERENCE 10: ELECTRODE 11: 1610 OHMS ELECTRODE 12: 2080 OHMS ELECTRODE 13: 2130 OHMS ELECTRODE 14: 2280 OHMS ELECTRODE 15: 2160 OHMS REFERENCE 11 ELECTRODE 12: 1530 OHMS ELECTRODE 13: 1810 OHMS ELECTRODE 14: 2030 OHMS ELECTRODE 15: 1950 OHMS REFERENCE 12: ELECTRODE 13: 1630 OHMS ELECTRODE 14: 2050 OHMS ELECTRODE 15: 2050 OHMS REFERENCE 13: ELECTRODE 14: 1680 OHMS ELECTRODE 15: 1910 OHMS REFERENCE 14 ELECTRODE 15: 1640 OHMS GROU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777221 ↗
• InjuryNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS 3 OR 4 MONTHS AGO THEIR INS BATTERY FAILED; PT WAS TOLD ONLY 4 BATTERIES FAILED WITHIN 100,000 BATTERIES. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465699 ↗
• InjurySep 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS 3 OR 4 MONTHS AGO THEIR INS BATTERY FAILED; PT WAS TOLD ONLY 4 BATTERIES FAILED WITHIN 100,000 BATTERIES. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006567 ↗
• InjuryJul 17, 2025Failure to Interrogate; Battery Problem; Charging Problem; Communication or Transmission Problem; Failure to Interrogate; Battery Problem; Charging Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT (PT) STATING THE BATTERY FAILURE ¿ CHARGE WAS DONE WITH NO CONNECTIONS LOOSE. WE CHANGED ALL THE OUTSIDE COMPONENTS AND BATTERY, CHANGING OUT ALL THE OUTSIDE COMPONENTS + BATTERY. TO BE HONEST WITH YOU, THE PROCESS IS LESS THAN DESIRED. I DON¿T HAVE FAITH IN YOUR FACTORY AGENT. DON¿T APPEAR TO BE VERY QUALIFIED, JUST KEEP SENDING FOR PARTS. I UNDERSTAND THIS IS AN ODD PROBLEM BUT THAT IS STILL NOT AN ACCEPTABLE EXCUSE. I SELECTED THIS BECAUSE I THOUGHT YOU WERE THE BEST DECISION. SEEMS LIKE A POOR DECISION NOW. WE SUPPOSEDLY HAVE AN NEW INTERNAL BATTERY COMING, SURGERY TO REPLACE IS ON AUGUST 5TH. I SINCERELY HOPE WE GET IT BY THEN, IF NOT I WILL BE FORCED TO TAKE LEGAL ACTION. JUST TO GIVE YOU MORE BACKGROUND, THE STIMULATOR HAS REDUCED MY PAIN SUBSTANTIALLY AND NOW I AM IN WORSE SHAPE THAN EVER. I CHOSE THIS BECAUSE MY OLDEST SON HAS A DEVICE THAT REDUCED SEIZURES FROM A BRAIN INJURY AND WAS VERY IMPRESSED WITH THE DEVICE¿S PERFORMANCE AND THE LOCAL REPS. ON A POSITIVE NOTE, THE REP HAS BEEN VERY GOOD TO WORK WITH. LAST BUT NOT LEAST, I WANT YOU TO KNOW I AM IN THE HVAC SERVICE BUSINESS AND WOULD BE VERY DISAPPOINTED IF MY PEOPLE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528436 ↗
• MalfunctionMay 7, 2025Failure to Deliver Energy; High impedance; Energy Output Problem; Therapeutic or Diagnostic Output Failure; Failure to Deliver Energy; High impedance; Energy Output Problem; Therapeutic or Diagnostic Output Failure

  CALLER TOLD BY PT THAT PT SEEING SETTINGS NOT AVAILABLE ON THEIR CONTROLLER STARTING ON MAY 4. CALLER SAW PT MAY 5 TO DO REPROGRAMMING. PT DID HAVE HIGH IMPEDENCE'S ON ONE ELECTRODE (WHICH ONE IS UNKNOWN BY CALLER) BUT THIS WASN'T BEING USED IN PROGRAMMING. PT USING DTM STYLE OF PROGRAMMING BUT WAS FEELING STIMULATION YESTERDAY DURING REPROGRAMMING SESSION. CALLER MADE SOME CHANGES TO PT'S SETTINGS INCLUDING LOWERING PULSE WIDTH TO A MUCH LOWER LEVEL. PER CALLER, PT USING ABOUT 4MA FOR INTENSITY. THE PT HAS ONLY BEEN USING GROUP B SO UNKNOWN IF GETTING OUT OF REGULATION (OOR) ON OTHER GROUPS. CALLER IS GOING TO TRY TO SEE PT TOMORROW AGAIN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976820 ↗

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