Inceptiv™ 977119 (UDI 00763000984687)Recalls & reported problems

Summary

The FDA's MAUDE database contains 513 adverse event reports that list this exact device (DI 00763000984687), received between Aug 28, 2025 and Sep 30, 2026 — classified as 186 injuries, 327 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (91 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 513 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Display or Visual Feedback Problem; Energy Output Problem; Electromagnetic Compatibility Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949575 ↗
• MalfunctionSep 30, 2026High impedance

  Information was received from a manufacturer representative (rep) regarding a patient (pt) with an implantable neurostimulator (INS). Pt was being implanted with a new system. During the procedure impedances were tested. It was found that the 9 and 10 electrode were showing high impedances as well as a poor connection on the lead. Rep also reports troubleshooting performed by the surgeon as: The lead was pulled and cleaned twice. The port of the battery was suctioned out in case fluid made its way into the battery port. When tested again it showed the same high impedance/poor connection. For safety of the patient (the lead was anchored into place and the top tissue closed) it was decided by the surgeon to move forward. In the post op area, another impedance test was performed and it showed the 1,2,8,9,10 electrodes showing high impedances. We were able to program the patient successfully and get full coverage of her painful areas in the lower legs. No symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947515 ↗
• MalfunctionSep 30, 2026Malposition of Device; Charging Problem

  Information was received from patient (pt) regarding an implantable neurostimulator (INS). It was reported that their INS was placed on a curve on their back and have troubles charging INS since they had it. Patient informed their healthcare provider (HCP) about it, but patient was not willing to have another surgery. Patient mentioned that they just have to be in a still position to get it to charge.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946026 ↗
• InjurySep 29, 2026Failure to Interrogate; Unstable; Communication or Transmission Problem; Patient Device Interaction Problem

  Patient problems: Discomfort; Insufficient Information; Swelling/ Edema

  MAUDE report 50936344 ↗
• InjurySep 29, 2026Migration or Expulsion of Device; Unintended Collision

  Patient problems: Pain

  MAUDE report 50934227 ↗
• MalfunctionSep 29, 2026Failure to Interrogate; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934224 ↗
• MalfunctionSep 29, 2026Battery Problem; Charging Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The pt reported that the newly implanted INS battery was not working well. They stated that the INS had been implanted in November and that they had needed to charge it frequently. Pt reported first noticing the issue about 3 months after implantation. They stated that the battery did not last more than 12 hours. Pt mentioned using SCS to avoid taking analgesic medication and expressed dissatisfaction with the device's battery performance. Agent reviewed INS battery duration. The pt was redirected to their healthcare provider (hcp) to further address the issue. Pt mentioned that they had contacted their HCP but had not yet received a response.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933874 ↗
• InjurySep 29, 2026Malposition of Device; Charging Problem; Communication or Transmission Problem

  Patient problems: Burning Sensation

  MAUDE report 50933831 ↗
• MalfunctionSep 29, 2026Electromagnetic Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928904 ↗
• MalfunctionSep 28, 2026Electromagnetic Compatibility Problem

  Information was received from a manufacturer's representative regarding an implantable neurostimulator. The reason for call was representative said patient had a cardioversion yesterday and the device is not functioning correctly. Representative said they are about to see patient in 30 minutes but it's going to be a super quick appointment and they have to go to the next appointment. Agent asked if patient turned therapy off for the cardioversion procedure and representative said they did. Technical Services(Ts) reviewed resetting neurostimulator to see if that will allow device to function. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916390 ↗
• InjurySep 25, 2026Failure to Interrogate; Unintended Collision; Communication or Transmission Problem

  Patient problems: Discomfort; Pain

  MAUDE report 50902686 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation; Patient Device Interaction Problem

  Information was received from a patient regarding the external equipment. The reason for call was patient stated that when they lay down on the mattress they can't move because it feels like electricity is going all the way through their legs. Patient stated that they went to bed last night and turned off the stimulator and now they cannot get it to turn back on. Agent walked patient through connecting the handset and communicator to the implant. PT was able to connect to the INS and was able to turn the therapy back on. Pt will monitor the issue and call back if needed.

  Patient problems: Ambulation or Postural Difficulties; Electric Shock

  MAUDE report 50899782 ↗
• MalfunctionSep 25, 2026Electromagnetic Interference; Failure to Deliver Energy; Battery Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported they have been getting Service Code 323 for the past 2 or 3 days. Patient stated the message has appeared up a couple times and they tried to turn their stimulation back on and recharged their battery to 100% and usually when they recharge the implant it lasts for a couple days; however, the implant battery discharged overnight. Agent asked patient if they had a recent defibrillation or cardioversion procedure and patient confirmed they had defibrillation. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898877 ↗
• InjurySep 25, 2026Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Insufficient Device Problem Information

  On (b)(6) 2026, (b)(4) (con): Information was received from a patient with an implanted neurostimulator (INS). They stated that they have unfortunately been dealing with significant issues with their SCS recently. While this has been an incredibly frustrating and painful experience, the support they have received from manufacturer representative (rep) has been nothing short of exceptional. Rep helped get patient's trial moving, helped coordinate the transition to their permanent implant, and has been present for all of their procedures. When their SCS was working well, rep took the time to work with patient and helped patient to achieve some truly amazing results. More recently, as they had been experiencing problems with their SCS, both reps have continued to be incredibly supportive and compassionate. What has meant the most to them is that their support hasn't disappeared now that things have become difficult. While patient was hospitalized, reps checked on them daily. They continued reaching out to see how patient was doing and have actively tried to help patient get answers regarding the problems they were experiencing. (b)(6) 2026, e1 (con): Additional information was receive

  Patient problems: Distress; Electric Shock; Loss of consciousness; No Clinical Signs, Symptoms or Conditions; Pain; Thrombosis/Thrombus

  MAUDE report 50898809 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation

  Information was received from a healthcare provider regarding an implantable neurostimulator. The reason for call was caller reported the patient has been experiencing shocking since yesterday. Caller stated they turned the stimulation down for the patient yesterday and it stopped shocking them for a little bit, but then it started shocking them again. Caller said the patient got fed up with it and turned the therapy off so they could get some sleep. Caller then stated this morning the patient turned stimulation back on, caller decreased it again but patient is still feeling shocking. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Electric Shock

  MAUDE report 50897563 ↗
• InjurySep 25, 2026Malposition of Device

  It was reported that the implantable neurostimulator was located at the belt line. A device revision was performed/planned, during which the implantable pulse generator pocket was moved approximately 5 inches higher, above the belt line. The issue was reported as resolved. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897061 ↗
• MalfunctionSep 25, 2026Charging Problem; Electromagnetic Compatibility Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). Patient reported they had an issue connecting their communicator and would get Communicator not Detected when trying to use MyStim RC. The issue began since day one. To agent's understanding patient seemed confused about their equipment so agent educated patient on the communicator, wireless recharger, MyStim RC, and Recharger Application. During the call patient restarted the communicator then entered the communicator serial number manually. Patient got Unable to Connect. Patient charged the implant and the implant was depleted. Agent reviewed information. Agent also reviewed adapter information and that patient could only charge one equipment at a time and to only have one cord plugged in at a time. Upon further review patient was trying to up and down their stimulation and their representative sent them 2 videos. Agent understood this as education for their implant. Patient called back and reported they had trouble since day one, March 10th, or a little bit after March 10th when charging their implantable neurostimulator (INS). Patient couldn't take a reading when trying to charge the im

  Patient problems: Pain

  MAUDE report 50895579 ↗
• MalfunctionSep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that devices were sent without allegations.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895168 ↗
• InjurySep 24, 2026Failure to Deliver Energy; Energy Output Problem

  Information was received from a patient's representative regarding an implantable neurostimulator (INS). The caller reported the patient had their therapy off because they had to go in the hospital for unrelated concerns and didn't want the therapy interfering with anything. Caller said they were trying to put the therapy back on today, but they couldn't get the patient to feel the "current." Caller said patient was typically on group C with intensity set to 7, which was what they were at when the therapy was turned off. Caller stated that because the patient wasn't feeling the current, they played with the settings and lowered the amount to 5.4 to see if that would work. When they tried to increase the amount, they got an error message that said 'Contact your clinician. Your Therapy turned off automatically... Service Code: 323.' Agent reviewed information and redirected to healthcare provider to further address the issue. Agent reviewed their role and a manufacturer representative (rep). Agent explained the issue would need to be resolv ed in person. Agent advised caller to reach out to healthcare provider (HCP) directly to page a rep if they wanted to coordinate with a local rep

  Patient problems: Insufficient Information

  MAUDE report 50886095 ↗
• InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock; Insufficient Information; Pain

  MAUDE report 50884849 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 50882977 ↗
• InjurySep 23, 2026Failure to Deliver Energy; Device Difficult to Program or Calibrate; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50873040 ↗
• InjurySep 23, 2026Break; Failure to Deliver Energy; High impedance; Battery Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  Information was received from a health care provider (HCP) via a manufacturer representative (rep) regarding a patient (pt) with an implantable neurostimulator (INS). The reason for call was that the caller reports that the patient had a change in therapy 3-4 weeks ago. The patient went to the healthcare provider last Monday for reprogramming. The healthcare provider ran an impedance check and found that the impedances were all out of whack. Caller reports that all contacts were showing greater than 40, 000 ohms except for 2 contacts, 0 and 8, which are at 32350 ohms and 32305 ohms. The caller indicated that there were no falls or trauma. HCP sent patient for imaging on (b)(6) 2026. Review of x-rays, show the leads are 100% in the INS, and there are no kinks or sharp bends in the lead wires. The issue was not resolved through troubleshooting. HCP will schedule patient for INS replacement and return INS for analysis. Technical services reviewed to ensure the lead impedances to ensure issue isn't within the leads. Technical services sent the caller a return mailer kit to return the device for analysis. Additional information was received from the manufacturer representative (rep) sta

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

  MAUDE report 50871923 ↗
• InjurySep 23, 2026Failure to Deliver Energy

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient reported that they could not feel the stimulation since last Thursday even if their INS battery was fully charge to 100%. Agent had the patient check if the stimulation on instructing the patient to access the Mystim application then it prompted them to connect. Agent assisted the patient first to synchronize the handset and the communicator. During connection attempt, patient go Not found message. Agent had the patient retry the communication and was able to connect to Mystim application and turn On the Stimulation. But patient could not feel the stimulation, Agent redirected the patient to HCP to meet with manufacturer representative (rep).

  Patient problems: Insufficient Information

  MAUDE report 50871723 ↗
• InjurySep 23, 2026High impedance; Malposition of Device; Charging Problem

  Additional information was received from the manufacturer representative (rep). It was reported that there were high impedances. Electrode 1-32547. 2-40000. 3-26249. Reprogramming. During planned pocket revision on 9/25/26 the surgeon will check leads and impedances. A device site infection was also reported with fluid discharge and pain at the INS site. Surgeon has planned to revise INS in the pocket and check for infection. The issue is ongoing. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Fluid Discharge; Pain; Unspecified Infection

  MAUDE report 50870172 ↗

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