Intellis™ Pro 977118 (UDI 00763000558826)Recalls & reported problems

Summary

The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 00763000558826), received between Jan 31, 2025 and Sep 30, 2026 — classified as 1 death, 93 injuries, 203 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (53 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 297 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Electromagnetic Compatibility Problem

  Patient problems: Burning Sensation

  MAUDE report 50947523 ↗
• InjurySep 28, 2026Failure to Interrogate; Delayed Charge Time; Malposition of Device; Charging Problem; Communication or Transmission Problem

  Information was received from a manufacturer's representative regarding an external device. The reason for call was representative said the patient has had some trouble charging their implanted neurostimulator. Representative said when they connected the wireless recharger to the patient's implant, they saw a screen that said to hold it there for 20 minutes. Representative also said about 5 minutes in, the screen switched to the normal charging screen where it gives you the percentage and tells you excellent or good. Representative asked if there was something they were doing wrong or if it was normal. Agent asked representative if the patient uses the belt when they charges and representative said they do. The representative also mentioned that the patient went to charge the device the other day and it took about 1.6 hours to charge from 40% to 100%, but the patient saw the same screen when they went to put it on and it still had charge in it. They typically are able to recharge within a "normal" amount of time. Manufacturing representative (rep) states the implantable neurostimulator (INS) is superficial, but there is some "puffiness" and the patient told her that it actually see

  Patient problems: Insufficient Information

  MAUDE report 50916874 ↗
• MalfunctionSep 28, 2026Delayed Charge Time; Charging Problem

  Information was received from a patient's (pt) representative regarding an implantable neurostimulator. The reason for call was Caller reported that for a while, the patient has been having issues with recharging the implant. Caller stated that it has been taking 3 hours plus to charge the implant and it only got to 60%. Caller stated sometimes pt gets good condition and sometimes excellent. Patient was not on the line and caller did not have the recharger with them at the time of the call. Agent asked caller if patient has had any falls or trauma and caller stated no, patient is in bed most of the time. Caller stated that the rep said the charger may be 'going bad' and we would be the ones to replace it. Pt rep will call back when they are available to troubleshoot with external devices.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915454 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare provider (HCP) reported that the patient had an infection with their spinal cord stimulator that led to the patient having the spinal cord stimulator explanted about 3 weeks after implant date.

  Patient problems: Unspecified Infection

  MAUDE report 50855320 ↗
• InjurySep 21, 2026Failure to Deliver Energy

  Patient problems: Insufficient Information

  MAUDE report 50845955 ↗
• InjurySep 21, 2026Overheating of Device

  Information was received from a patient regarding an implantable neurostimulator (INS). The patient stated they had been having problems with their stimulator. Patient said their back was swelling where the stimulator was and when they tried to recharge, the implant would get hot and was "burning" to the point where it became painful and they would have to stop charging. Patient mentioned they had an appointment with their doctor and the manufacturer representative (rep) was just at the office too so patient explained what was going on, and the representative told patient to call to see if there was anyone there that had heard of a problem previously and that patient might need an "antenna" replacement or something. Patient confirmed it was the implant that felt like it was getting hot. The issue was not resolved. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Burning Sensation; Pain; Swelling/ Edema

  MAUDE report 50842072 ↗
• MalfunctionSep 18, 2026High impedance; Energy Output Problem; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820000 ↗
• MalfunctionSep 16, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796440 ↗
• InjurySep 11, 2026Inappropriate/Inadequate Shock/Stimulation

  Information was received from a manufacturer's representative regarding patient with an implantable neurostimulator (INS). The reason for the call was caller reported the patient is in the hospital because they were feeling shocking all over their body along with cramps and the patient believes it is related to the device. Caller stated stimulation was on when the shocking and cramping occurred so patient turned stimulation off but the symptoms continued, even after stimulation had been off for 1-2 days. Caller met with the patient in the hospital yesterday and confirmed everything was off but the patient was still getting shocks and cramps. Caller confirmed all connections and impedances were good. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue. Patient plans to see managing physician once they are out of the hospital.

  Patient problems: Cramp(s) /Muscle Spasm(s); Electric Shock; Insufficient Information

  MAUDE report 50734555 ↗
• MalfunctionAug 14, 2026Malposition of Device; Battery Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50252793 ↗
• InjuryJul 31, 2026Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  Additional information was received from the patient's managing physician (HCP). HCP reports there are no plans to remove the patient's stimulator. The patient reported experiencing shock like sensation when they turn to their side while laying down, the INS is not providing lasting pain relief despite multiple re-programming attempts. HCP reports pt has experienced stimulation in their abdomen. Pt has to charge the battery every day, for example if the battery is fully charged at midnight, with very little use it drops to 60% by 11:00am the next morning. HCP reports pt had x-ray of the thoracic spine on (b)(6)2026 showing the leads to be in place. The cause of these issues was not determined. HCP reports the pt's biggest concern is they do not seem to get as much relief as they did with the trial spinal cord stimulator. Their symptoms are attributed to severe mechanical nerve compression at L5-S1 fusion which involved mal-position of hardware. HCP reports the decision to implant the spinal cord stimulator was made to avoid a high-risk revision surgery, given pt's weight and other medical issues. HCP reports the pt was given the option to have the stimulator revised to a paddle lea

  Patient problems: Ambulation or Postural Difficulties; Electric Shock; Inappropriate Device Stimulation of Tissue; Insufficient Information

  MAUDE report 50098097 ↗
• InjuryJul 30, 2026Failure to Deliver Energy

  Information was received from a patient regarding an implantable neurostimulator (INS). The reason for call was patient reported they were not feeling any stimulation since yesterday. Agent had patient connect through MyStimRC; patient reported therapy was on and in Group C with program 1 at 7.4 and program 2 at 7.6. Patient confirmed Group C was the group they normally use. Agent had patient turn therapy off and back on; patient reported they felt no stimulation. Patient switched to Group A and reported they felt no stimulation and switched to Group B with the same result. Patient switched back to Group C and increased program 1 to 7.9; patient reported they still felt no stimulation. Agent reviewed role of manufacturer representative (rep) and the patient was redirected to their healthcare provider (HCP) to further address the issue.

  Patient problems: Insufficient Information

  MAUDE report 50078343 ↗
• InjuryJul 29, 2026High impedance

  It was reported that a patient experienced a return of pain in the setting of high impedance. The high impedance was not observed on the day of surgery, and impedance values were referenced as greater than 40 ,000. Programming was changed to working electrodes. Provider will order X-ray to verify lead placement.  The issue was reported as ongoing. The manufacturer representative (rep) indicated they would send any further information as they become aware. 2026-JUL-07 MPXR 1448886.1 (rep): Additional information was received from the manufacturer representative (rep). It was reported that the rep noted the top of the Right lead has migrated down to T9. 2026-JUL-13 MPXR 1448886.2 (rep): Additional information was received from the manufacturer representative (rep). The same rep later noted conflicting information that they met with patient today with return of pain. x-rays were taken and leads are in the same position as implant day. High impedances are noted on electrodes 1,2,3,4,6,12,13,14. Rep programmed around these electrodes and the patient will updated me at a later date with pain results.

  Patient problems: Pain

  MAUDE report 50074932 ↗
• InjuryJul 29, 2026Failure to Deliver Energy

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was pt reported their therapy was turning off by itself. Pt said it first happened 3 weeks ago, but they just turn it back on and let it go. Pt said it happened again today, they were feeling pain, so they had checked their INS battery on the therapy application thinking the battery went dead, but it was at 70%. Pt said their INS and communicator battery never run low, but their therapy was shutting itself off. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Pain

  MAUDE report 50070878 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient wanted to know what to do with their external devices now that the INS was removed. Patient reported they had to surgically remove their spinal cord stimulator because it was covered with an infection. Patient stated they had to have three major spine surgeries over the "past 10 weeks;" patient was in surgery on April 1st for 8.5 hours, May 1st for 6 hours, and on "the 19th" for 4 hours. Agent asked when the infection first started showing sign/symptoms; patient stated on about May 10th the infection was noticed because the patient's spinal fluid was leaking, which lead to the discovery of the infection "running rampant." On "the 19th"  they had the implantable system explanted. Agent asked if all or part of the INS was removed; patient stated they "guessed" the entire system was removed because the surgeons had to "go in and rebuild it, because everything collapsed." Patient additionally stated they had been in bed since April 1st because they lost all feeling in their legs.

  Patient problems: Cerebrospinal Fluid Leakage; Insufficient Information; Numbness; Unspecified Infection

  MAUDE report 50070086 ↗
• MalfunctionJul 17, 2026Failure to Deliver Energy; Data Problem

  Patient problems: Pain

  MAUDE report 25858384 ↗
• MalfunctionJul 17, 2026Therapy Delivered to Incorrect Body Area; Battery Problem

  Patient problems: Device Overstimulation of Tissue; Inappropriate Device Stimulation of Tissue

  MAUDE report 25857878 ↗
• MalfunctionJul 16, 2026Failure to Interrogate; Use of Device Problem; Delayed Charge Time; Charging Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25841132 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A DEVICE SITE INFECTION. THE PATIENT HAD NO ADDITIONAL SYMPTOMS REPORTED. THE NEUROSTIMULATOR AND LEAD WERE SUCCESSFULLY REPLACED AND DISCARDED BY THE CUSTOMER. 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: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 25779382 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF PAIN AND INADEQUATE PAIN RELIEF. THE ISSUE WAS REPORTED AS ONGOING AND NOT RESOLVED. DEVICE REMOVAL WAS REPORTED, AND THE PATIENT WAS SCHEDULED TO HAVE THE DEVICE EXPLANTED IN LATE (B)(6) 2026. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Pain

  MAUDE report 25664908 ↗
• MalfunctionJun 22, 2026Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THEY CAN'T MAKE AN ADJUSTMENT TO THE PROGRAM, THEIR LEGS WERE NUMB AND IT HAD NOT BEEN A GOOD 24 HOURS. PATIENT MENTIONED THEY WERE SO SORE YESTERDAY, THEY HAD TO LEAVE THE RODEO EARLIER BECAUSE THEY COULDN'T SIT THERE AND THEIR LEGS HAD ELECTRICITY BUZZING DOWN THEM. PATIENT STATED THAT THEY WERE ABLE TO CHARGE THEIR IMPLANT LAST NIGHT AT MIDNIGHT. PATIENT NOTED THAT THE HANDSET WAS NOT SYNCING TO THE PANCAKE AND THEY COULDN'T BRING THE PHONE UP TO SEE IF THEY COULD MAKE ADJUSTMENTS INTO THE PROGRAMS THEY HAD IN THERE. PATIENT MENTIONED THAT THEY HAD ANOTHER STIMULATOR WAS FOR THEIR ARMS AND THAT WAS THE BEST THING THEY EVER DID FOR THEM AND THEIR ARMS WORKED PERFECTLY. PATIENT NOTED THE INTELLIS PRO WAS FOR THEIR LEGS AND THE OTHER IMPLANT WAS FOR THEIR ARMS, BUT THIS IMPLANT HAD BEEN A PAIN EVER SINCE THEY GOT IT (AGENT UNDERSTOOD PATIENT WAS REFERRING TO THEIR INTELLIS PRO IMPLANT). PATIENT WAS WORKING WITH MANUFACTURER REPRESENTATIVE (REP) TO ADJUST THE STIMULATOR. AGENT WALKED PATIENT THROUGH RESETTING THE COMMUNICATOR. PATIENT OPENED THE MYSTIM APP

  Patient problems: Electric Shock; Numbness; Pain

  MAUDE report 25588557 ↗
• MalfunctionJun 18, 2026Delayed Charge Time; Charging Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PATIENT REPORTED THEY HAD A PROBLEM WITH THE WIRELESS RECHARGER (WR). PATIENT SAID THEY WERE HAVING A HARD TIME MAINTAINING A CONNECTION TO CHARGE THE IMPLANTED NEUROSTIMULATOR (INS) FOR PROBABLY 2 MONTHS. PATIENT MENTIONED THEY SPENT A LOT OF TIME SITTING AND TRYING TO CHARGE THE INS, MUCH LONGER THAN WHEN THEY STARTED; 2 HOURS TO CHARGE THE INS HALFWAY, AND IF THEY MOVE A TINY BIT THE CONNECTION WAS LOST. PATIENT HAD A HARD TIME FOLLOWING WHAT AGENT WAS ASKING THEM TO DO THROUGHOUT THE CALL AND DID NOT USE THE BELT OR RECHARGER APPLICATION PRIOR. AGENT ASKED, PATIENT SAID THEY DIDN'T KNOW HOW FULLY CHARGED THEIR IMPLANT WAS. PATIENT TRIED TO START A CHARGING SESSION OF THEIR IMPLANT, BUT SAID THE WR WAS BEEPING EVEN IF THEY WERE OVER THE IMPLANT SITE. AGENT HAD PATIENT USE THE RECHARGER APPLICATION TO LOCATE THE SPOT TO CHARGE, BUT PATIENT WAS UNABLE TO FIND THE RECHARGING APPLICATION; AGENT HAD TO GUIDE THE PATIENT TO ADD THE APP BACK TO THEIR HOME SCREEN. PATIENT MENTIONED THEY TRY TO CONNECT, BUT SOMETIMES IT WOULD JUST BE DEAD (AGENT WAS NOT QUITE SURE WHAT THE PATIENT WAS TALKING AB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548657 ↗
• MalfunctionJun 17, 2026Charging Problem

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT REP REPORTED THEY HAD TO CHARGE THE INS, THE SCREEN SHOWED THERAPY WAS ON, THEY WERE CHARGING THE INS FOR 30 MINS, BUT THE BATTERY LEVEL DIDN'T MOVE FROM 'BLINKING RED' AND TAKING SO LONG TO FULLY CHARGE. PT REP SAID THE ISSUE STARTED TODAY. AGENT REVIEWED INS CHARGING DURATION. AGENT INSTRUCTED PT REP TO KEEP CHARGING THE INS AND MONITOR THE ISSUE. PT REP WILL CALL BACK IF THE ISSUE CONTINUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25539922 ↗
• MalfunctionJun 15, 2026Data Problem

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THEIR STIMULATION IS SURGING SINCE 2 DAYS AGO. PATIENT STATED THEY ARE ON 3.2 IN DIFFERENT POSITIONS AND WHEN THEY ARE SITTING DOWN THE STIMULATION WILL GO TO 5 ON ITS OWN. PATIENT STATED THEY CAN STAND UP AND THEN STIMULATION WILL COME BACK DOWN. PATIENT STATED HE USED TO HAVE A REP CONTACT INFORMATION BUT LOST IT. PATIENT STATED THEY GO TO PAIN SPECIALIST CLINIC AND DID NOT HAVE DOCTOR (HCP) NAME. AGENT REVIEWED ADAPTIVESTIM FEATURE AND PATIENT SAID HE WILL TRY TO CHANGE THE SETTING ON HIS OWN AND CALL HCP OFFICE IF NECESSARY. AGENT REVIEWED REPS ROLE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25511275 ↗
• MalfunctionJun 15, 2026Failure to Deliver Energy; High impedance; Energy Output Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INABILITY TO ADJUST GROUPS ON THE REMOTE AND FEELING TONIC STIMULATION. AN IMPEDANCE CHECK WAS PERFORMED AND IDENTIFIED HIGH IMPEDANCE ON MULTIPLE CONTACTS, WITH CONTACTS 1, 2, 4, 8, AND 10 DOCUMENTED AT 40,000, AND MULTIPLE CONTACTS MARKED AS ¿AVOID,¿ INCLUDING CONTACTS 1, 2, 4, 8, 10, AND CONTACT 0. PROGRAMMING WAS PERFORMED AROUND THE HIGH IMPEDANCES, AFTER WHICH THE PATIENT REPORTED GREAT COVERAGE. THE ABILITY TO MAKE NECESSARY ADJUSTMENTS ON THE REMOTE WAS DOUBLE-CHECKED AND ADJUSTMENTS WERE ABLE TO BE MADE. THE ISSUE WAS REPORTED AS RESOLVED, AND NO PATIENT INJURY OR ADVERSE OUTCOME WAS REPORTED. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

  Patient problems: Insufficient Information

  MAUDE report 25503652 ↗

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