Inceptiv™ 977119 (UDI 00763000540302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,339 adverse event reports that list this exact device (DI 00763000540302), received between Jun 19, 2024 and Sep 30, 2026 — classified as 405 injuries, 934 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (224 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,339 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Therapy Delivered to Incorrect Body Area

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50948741 ↗
• InjurySep 30, 2026Energy Output Problem; Charging Problem; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50948335 ↗
• MalfunctionSep 30, 2026Migration or Expulsion of Device

  Information was received from a patient regarding an implantable neurostimulator. The reason for the call is pt states about they wanted to follow-up with a manufacturing representative (rep) regarding the MRI that was done about 1-1.5 months ago that showed "a couple of the leads have dropped". Agent reviewed rep role and redirected to the hcp. Agent sent email to the reps in the field. Additional information from the manufacturing representative (rep) indicated that the patient's hcp has been out, and they have not seen the patient. The rep indicated that they will work to schedule the patient for a reprogramming and try and reprogram based on the new lead position.

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

  MAUDE report 50946847 ↗
• InjurySep 30, 2026Battery Problem

  Patient states the therapy has stopped working effectively and the battery is draining completely in two days.

  Patient problems: Insufficient Information

  MAUDE report 50946513 ↗
• MalfunctionSep 29, 2026Use of Device Problem; Delayed Charge Time; Charging Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient said that they couldn't charge INS, and it was taking a long time to charge INS and could be hard to find the right spot to charge. During the call they did long press on wireless recharger and then went into recharging application and tried to charge. They reported seeing the recovery mode screen. PT was going to continue in recovery mode and will then charge INS when they have time to do it and will call patient services back if they have any issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937340 ↗
• MalfunctionSep 29, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937202 ↗
• MalfunctionSep 29, 2026Failure to Deliver Energy; Battery Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (INS). The reason for call was rep reported that the patient (pt) had likely had a cardioversion yesterday because the patient was having heart issues and then the patient fell and was in the ICU today. manufacturer representative (rep) said the pt's implanted neurostimulator battery was not holding a charge. Rep said the tablet displayed message therapy off, contact your clinician: therapy is turned off, cannot provide the requested therapy, amplitude will be set to 0 in all active groups when trying to connect to INS. Rep tapped "set amplitudes to 0" and then got System error: 0X2CC6BEDE. During the call, the representative attempted to connect to the patient's Implanted Neurostimulator, but got a system error message. Rep reset stimulator 2 times and tried to connect to INS again, but got same amplitudes to 0 message followed by system error. Rep tried to connect to INS with pt programmer and got Service code 323. Rep said the only thing the pt could do is charge the INS. Technical Services (TSS) discussed likely cardioversion damage. No symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934477 ↗
• InjurySep 29, 2026Failure to Deliver Energy; Insufficient Device Problem Information

  Patient problems: Pain

  MAUDE report 50934245 ↗
• InjurySep 29, 2026High impedance; Unintended Collision

  Patient problems: Pain

  MAUDE report 50933726 ↗
• InjurySep 29, 2026Overheating of Device

  Patient problems: Burning Sensation

  MAUDE report 50932336 ↗
• InjurySep 28, 2026Failure to Interrogate; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  Information was received from a patient regarding an implantable neurostimulator (INS). The reason for call was Patient reported they are not able to charge the implant for a month. Patient stated they are getting Code 4100 and 4101 when they are trying to charge the implant. Patient mentioned they have an appointment today with a different doctor and will bring up the issue to them. Agent asked patient if they have had falls or trauma and patient said no, but they have always had trouble charging the implanted neurostimulators since they got the implant about a year ago. Agent reviewed meaning of the message and recommend patient consult with healthcare provider for next steps. The issue was not resolved. The patient was redirected to their healthcare provider to further address the issue. Additional information was received from the manufacturer representative (rep). It was reported that the patient states a few months ago her device "stopped working" and she could not connect her handset to the implantable neurostimulator (INS). Patient states she called patient services about the communication issues and was redirected to her surgeon for replacement. She would like to have a no

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915691 ↗
• MalfunctionSep 28, 2026Unintended Collision; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915483 ↗
• InjurySep 24, 2026Failure to Deliver Energy; Energy Output Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator. The reason for call was patient said that they "don't feel it as much in my lower back as I should and if I turn it up I feel it more in my legs". They said this started about a month ago. PT reports no falls or trauma. PT says that "on group A and B, I can feel it in my back and on groups C and D I feel it in my legs and it's kind of numb, but I don't feel it in my back". Since patient has tried all available groups, recommended they consult with healthcare provider (HCP). The issue was not resolved. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Inappropriate Device Stimulation of Tissue; Numbness

  MAUDE report 50884894 ↗
• MalfunctionSep 24, 2026Delayed Charge Time

  Information was received from Patient (pt) regarding an external device. The reason for call was patient (Pt) reported that every time they charge the implantable neurostimulator (INS), the controller on their left side turned itself off in the middle of charging and that they have to turn it back on, it had been doing it for several weeks now.  Pt confirmed that Bluetooth was on and Airplane mode was off. Agent had pt close all applications, launch the Recharger application, turn on the wireless recharger (WR), place the WR over the INS, and attempt to recharge. Pt confirmed that therapy was off, the INS battery level was 0%, and the recharging quality fluctuated from good to excellent and back to good. Pt noted that the handset screen turned off. Agent had pt relaunch the Recharger application, and the pt confirmed that the INS was still recharging. Agent had pt adjust the handset screen timeout to 10 minutes. Agent reviewed information and confirmed that the wireless recharger (WR) and implantable neurostimulator (INS) were working as e xpected. Pt called back and reported the same information. They said on their left side stimulator, when they charge it, the light on the commun

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884500 ↗
• MalfunctionSep 24, 2026Delayed Charge Time

  Information was received from Patient (pt) regarding an external device. The reason for call was patient (Pt) reported that every time they charge the implantable neurostimulator (INS), the controller on their left side turned itself off in the middle of charging and that they have to turn it back on, it had been doing it for several weeks now.  Pt confirmed that Bluetooth was on and Airplane mode was off. Agent had pt close all applications, launch the Recharger application, turn on the wireless recharger (WR), place the WR over the INS, and attempt to recharge. Pt confirmed that therapy was off, the INS battery level was 0%, and the recharging quality fluctuated from good to excellent and back to good. Pt noted that the handset screen turned off. Agent had pt relaunch the Recharger application, and the pt confirmed that the INS was still recharging. Agent had pt adjust the handset screen timeout to 10 minutes. Agent reviewed information and confirmed that the wireless recharger (WR) and implantable neurostimulator (INS) were working as e xpected. Pt called back and reported the same information. They said on their left side stimulator, when they charge it, the light on the commun

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884497 ↗
• InjurySep 24, 2026Failure to Deliver Energy

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported they were having issues with their stimulation. Patient went through their 4 groups and went up to 10 and 15 and they got no stimulation at all on any of them. Patient was getting nothing except pain in the L4 and L5 area about the size of a small apple. Patient mentioned both their batteries were completely charged. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: Pain

  MAUDE report 50884053 ↗
• MalfunctionSep 24, 2026Low impedance

  It was reported that an ongoing unresolved low impedance or short issue occurred involving electrode 0 and electrode 8, with an impedance value of 244. The cause of the issue was unknown. No action was taken, and the issue remained ongoing. 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

  MAUDE report 50883593 ↗
• InjurySep 23, 2026Therapy Delivered to Incorrect Body Area; Battery Problem; Charging Problem

  It was reported that the implantable neurostimulator remained implanted and in service, and the patient reported pain at the implantable neurostimulator site. After recharging to 40%, the charge reportedly lasted approximately 2 days. The battery reportedly depleted to 0% and the neurostimulator shut off on two occasions. The patient began charging the device daily when it reached 40%. While lying down, the patient reported that stimulation vibrated into the stomach, which had not been previously experienced. Telephone troubleshooting was performed, and an in-person appointment was scheduled to interrogate the battery. The issue remained ongoing and unresolved. No adverse outcome was reported. The manufacturer representative (rep) indicated they would send any further information as they become aware.

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50871952 ↗
• InjurySep 23, 2026Energy Output Problem

  Patient problems: Burning Sensation; Insufficient Information; Pain

  MAUDE report 50871795 ↗
• InjurySep 23, 2026Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  The reason for the call was HCP reported pt felt shooting pains from under the stimulator and pt was not getting pain relief benefits from the stimulator. HCP said pt thought there was something wrong with the stimulator. HCP said a CT had been performed and radiologist did not see anything wrong with INS pocket site. TSS discussed issue and provided NAS. Pt was redirected to managing HCP. Information was received from a patient's representative regarding an implantable neurostimulator (INS). The reason for call was caller reported the pt was hospitalized yesterday because she was experiencing pain around the implant area and a shocking sensation on the leads. The caller said the issue started Sunday early morning. Agent advised they can turn off the pt therapy. Caller said they were trying to call the pt MDT rep but no reply. The caller was redirected to their healthcare provider to further address the issue. Agent provided NAS phone number.

  Patient problems: Electric Shock; Pain

  MAUDE report 50868160 ↗
• InjurySep 22, 2026Unintended Collision; Overheating of Device

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (INS). The reason for call was the patient had a fall while on a fishing boat. The patient reported that since the fall the INS feels warm in their chest. The caller plans to meet with the patient.

  Patient problems: Burning Sensation

  MAUDE report 50857288 ↗
• MalfunctionSep 22, 2026Battery Problem; Charging Problem

  Information was received from a patient regarding an implantable neurostimulator. The reason for call was patient reported they hadn't used their device in over a year because it wasn't working right. Patient stated the implant was supposed to last at least a month but they were having to charge the implant every single day. The issue began ever since they were implanted. Patient mentioned they were kind of scared to put stuff on their back. Agent reviewed information. Patient charged the handset but hadn't charged the recharger. Agent advised patient to charge the recharger then to charge the implant and to call back for assistance if needed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855633 ↗
• InjurySep 21, 2026Display or Visual Feedback Problem; Data Problem

  Patient problems: Pain

  MAUDE report 50846083 ↗
• InjurySep 21, 2026Failure to Deliver Energy; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was pt stated they have a problem with the phone and the battery in their back. Agent reviewed INS battery depletion. Pt stated normally, it lasts 24 hours for them and changes when laying on their back or side. Pt stated they have noticed this the past couple days. Pt stated they have had the same settings since INS was turned on and they didn't have problems when they first started using it when it was programmed. Agent understood that pt was fully charging the INS to 100% and then in the morning, the therapy is Off. Pt stated they had to shut off with the charger this morning. Pt stated this 'whole thing is a pain' and they want it out of them. Pt stated the battery in their back dies so fast and the phone is shutting off. Agent reviewed information. Pt added that the INS battery was 90% and the 'battery was off' (agent could not understand what the pt was saying). Pt added that they are still in pain, their muscle tissue is sensitive, they can feel in their spine, and they have the same feeling for the past 6 years. Pt sated they have pain in their muscles if they st

  Patient problems: Discomfort; Electric Shock; Insufficient Information; Pain

  MAUDE report 50841635 ↗
• InjurySep 17, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812347 ↗

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