InterStim™ X 97800 (UDI 00763000484668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,930 adverse event reports that list this exact device (DI 00763000484668), received between Mar 8, 2022 and Sep 30, 2026 — classified as 2,605 injuries, 3,325 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1,318 reports).

7 other recalls cover devices cleared under the same FDA submission (P080025, P970004); 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 5,930 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Discharge of Battery

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that they had some surgery up at Cleveland Clinic and they were going to turn off the MRI turnoffs that stimulated for the MRI, but it wouldn't work at all. The patient said earlier this year they had an MRI of their prostate, and it worked fine, but between May and September 22nd when they had the surgery, the battery died in the device. Patient asked why the battery would have expired so soon. Agent reviewed battery longevity information with the patient. Patient mentioned that their previous implant always used up and even in the old one that was not MRI compatible, they always had to use about 4.2 source of stimulation. 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 50950306 ↗
• InjurySep 30, 2026Electromagnetic Compatibility Problem

  Patient problems: Incontinence; Insufficient Information

  MAUDE report 50948716 ↗
• InjurySep 30, 2026Disconnection; Migration or Expulsion of Device; Insufficient Device Problem Information

  Patient problems: Insufficient Information; Pain; Urinary Frequency / Polyuria

  MAUDE report 50947493 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50936298 ↗
• InjurySep 29, 2026Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that the caller reports that the patient has not used the implant because it has not been doing what it was supposed to be doing since within 6 months of being implanted in 2022. They tried turning it up until the point where it hurts and then back it back down. The caller reported that the patient also has Alzheimer's, so even if the device was working, they know what the impact would be with the Alzheimer's. The patient was scheduled for an MRI yesterday, but when they tried to activate MRI mode they saw a screen that the implant was too low and needed to be charged and they could not due the MRI. Reviewed that the implant is recharge free. The caller noted that the light on the communicator was yellow. Reviewed that it was likely the communicator that needed to be charged. Caller was not with the patient at the time of the call, but will call back to confirm what the screen was. Additional information was received from a friend/family member. The patient representative called back repeating event his

  Patient problems: Incontinence; Pain

  MAUDE report 50935485 ↗
• InjurySep 29, 2026Failure to Deliver Energy; Energy Output Problem

  Additional information was received from the patient. They reported that they already had their external devices with them and were able to access their therapy settings. The patient considered changing the program and decreasing the therapy settings to a comfortable level. It was reported that the cause of the therapy being off was determined. It was a mistake and was left off after an MRI. No further action would be taken.

  Patient problems: Discomfort

  MAUDE report 50935156 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock

  MAUDE report 50934364 ↗
• InjurySep 29, 2026Electromagnetic Interference; Insufficient Device Problem Information

  Patient problems: Diarrhea; Flatus; Insufficient Information

  MAUDE report 50934101 ↗
• InjurySep 29, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932659 ↗
• MalfunctionSep 29, 2026High impedance

  Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that the reason for the call was the representative said they were doing a lead revision (see 709415697) and they tested the new lead and 2 of the electrodes came back with high impedance every time. The representative said they put the old battery on and it gave different impedances. The 1 and 2 electrodes were over 4,000 ohms. The representative put the new battery back in and they gave the same value of being high. The representative confirmed they tightened the set screw and tugged on the lead to make sure it was secure. The representative had not tried getting motor response from the lead with the external battery. During the call, the representative was able to get motor response on all 4 electrodes. Electrode 1 & 2 that had high impedances got motor response at 0.4 mA. Technical Services (Ts) reviewed with caller that the impedance was good, even though it registered high. Ts stated that if impedance was truly high then the patient would not have gotten motor response at 0.4 mA. The issue wa

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932642 ↗
• InjurySep 29, 2026Break; Failure to Deliver Energy; Therapeutic or Diagnostic Output Failure

  Information was received from an unknown source regarding a patient who was implanted with an implantable neurostimulator (INS) for fecal incontinence and urinary dysfunction (Incontinence, Urgency, and/or Frequency). It was reported that there was a lead fractur ed/damaged/broken. The patient experienced a loss of stimulation in relation to the lead issue. Troubleshooting was not performed. It was reported that the cause was not known but it was however noted that the damage was caused or discovered during surgery. A stimulation output issue was noted and it was noted "max setting achieved". Troubleshooting was performed and multiple programs were tried, however the cause was not known. The issue was not resolved and no action was taken/no adverse outcome was noted. The device was explanted.

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

  MAUDE report 50927819 ↗
• InjurySep 29, 2026Electromagnetic Interference; Electromagnetic Compatibility Problem; Therapeutic or Diagnostic Output Failure

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for Urinary/bowel dysfunction. It was reported that they had an EMG last week and turned therapy off to be on the safe side but when they turned it back on they got the message: The System is Operating at Maximum Settings and their setting was program A, 1.5, they have not tried any other programs. The patient (Pt) said their note about program A said, up to 5.0 but pt did not recall what the amplitude had been before they turned it off for the EMG and pt said they were not sure if the Max Settings message appeared when they turned it off or not because they had been very nervous. Reviewed meaning of Max Settings message and asked pt to synch to their INS and navigate to the battery section, their MyBattery showed OK. Pt said they have not had any falls, they had several MRIs. The Pt also reported their symptoms were 50% improved over their baseline but their results were not the same as they were during the evaluation. The Pt said they still have to wear the heaviest pads all the time and run to the bathroom. The Pt said in the 3 months following the implant procedure they met with

  Patient problems: Anxiety; Incontinence

  MAUDE report 50927552 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction and urge incontinence. It was reported that caller reported a return of symptoms for the past 3-4 days. Caller stated that they have been having to use their catheter every day, multiple times a day (implanted for urinary retention). Caller added that sometimes it happens for a day or two and then they don't need to use the catheter but it never happens consistently like this. Caller is wondering if the implant battery could have reached the end of its life. Caller stated they were going to use the handset to check the status or possible make an adjustment but they cant because the handset screen is damaged and it wont power on. Caller is worried that it might cause a UTI (stating their UTIs are severe and resistant and require IV antibiotics for 2 weeks) and they are trying to prevent that. The patient was redirected to their healthcare provider to further address the issue. screen is damaged and it wouldn't respond when trying to power on. redirected to sunMed portal called prs to update phone

  Patient problems: Urinary Retention

  MAUDE report 50927071 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50918285 ↗
• InjurySep 28, 2026Premature Discharge of Battery; Battery Problem

  Patient problems: Incontinence

  MAUDE report 50917655 ↗
• InjurySep 28, 2026Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction : Urinary Urge Incontinence The patient reported that they have the device placed in the right back.¿ They stated, ¿6 months ago they experienced burning in the right calf.¿ They went to their provider, and ¿a  representative lowered the setting, which helped with the burning. The burning gets worse when they have their leg hanging; it is better when they keep their leg straight.¿ The device is turned off ¿because the burning was going up to their right buttock.¿ The patient declined a new/list of providers,- will self-schedule,<(>,<)> and was provided with the number for an MDT Patient Representative.

  Patient problems: Burning Sensation

  MAUDE report 50916759 ↗
• MalfunctionSep 18, 2026Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820713 ↗
• MalfunctionSep 15, 2026Migration or Expulsion of Device; Unstable; Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778758 ↗
• InjurySep 8, 2026Unintended Collision; Extracardiac stimulation

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction and urge incontinence. It was reported that patient wasn't able to figure out what setting they should be at anymore. Patient stated that they were having a lot of UTI and frequent urination since December of last year, and that it started around the time that they had a fall back in December. Patient added that they also had many falls that they felt on the right side and that they would twist to their left side in their waist a lot. Patient then mentioned that they've met with their primary Healthcare provider( HCP) who gave them referrals for their stress and urinary urge/incontinence. During the call, agent reviewed general therapy information and walked patient through changing programs, but patient confirmed feeling the stimulation close to their INS location instead of their bicycle seat area.

  Patient problems: Distress; Inappropriate Device Stimulation of Tissue; Incontinence; Insufficient Information; Urinary Frequency / Polyuria; Urinary Tract Infection

  MAUDE report 50673112 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671092 ↗
• InjurySep 8, 2026Insufficient Device Problem Information; Patient Device Interaction Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction and urinary urge incontinence. It was reported that they were having accidents and were up at least 4 times a night. The patient said they were going to the bathroom every 1/2 hour to hour and wore diapers. The patient said they tried myrbetriq. The patient said one time they fell in the kitchen and when they were putting the board under the patient the patient was screaming in pain. The patient said they thought the device was damaged when this was done. The patient was redirected to their healthcare provider.

  Patient problems: Incontinence; Pain; Sleep Dysfunction; Urinary Frequency / Polyuria

  MAUDE report 50670179 ↗
• InjurySep 8, 2026Malposition of Device

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urge incontinence and urinary/bowel dysfunction. It was reported that the patient worked through all of the programs based on the information provided by the manufacturer representative (rep) regarding each of the programs. The patient said that therapy was working and their managing physician performed another test in (b)(6) or end of (b)(6) and realized that the implanted system might not have been implanted correctly the first time. The patient received a new implanted system on (b)(6) 2026. Documented reported event. No further action was taken by Patient Services. Additional information was received from a manufacturer representative (rep). The rep reported that they didn't remember when this event happened.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669835 ↗
• InjurySep 8, 2026Inappropriate/Inadequate Shock/Stimulation

  Information was received from an healthcare provider (HCP) via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction and urinary urge incontinence. It was reported that the patient was experiencing pain.  The issue was resolved.  No action taken/no adverse outcome.  The patient was seen in the office with the HCP.  After the patient reported a "shocking feeling". The patient denied shocking at battery site or with lead stimulation. The patient reported pain when initiating void. The program changed with the appropriate sensation. The patient denied discomfort.  The rep told the patient to follow up with the rep in 2 weeks. If the pain returned, the device should be turned off. The HCP agreed with the plan of care.

  Patient problems: Dysuria; Electric Shock; Pain

  MAUDE report 50669331 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urge incontinence and urinar y/bowel dysfunction. It was reported that they were getting an MRI of their spine/neck and were trying to put the device into MRI mode but were getting EOS message. Reviewed meaning of the message and redirected patient to their healthcare provider to further address the issue. The patient complained that the INS battery did not last long. The patient stated they had amplitude around 3.0 and were turning the therapy off twice a week. The patient stated they would contact their physician to request device removal.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668187 ↗
• InjurySep 7, 2026Migration or Expulsion of Device; Unintended Collision; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50645254 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080025, P970004. One submission often covers many models, so check the product and lot details in each record.

• Z-1704-2025 · Apr 3, 2025 · Open, Classified
  Enhanced Verify Evaluation Handset (CFN HH90130FA)
• 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-2365-2023 · Jul 6, 2023 · Open, Classified
  Medtronic InterStim Ground Pad REF 041826
• Z-0998-2022 · Feb 28, 2022 · Terminated
  MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA,
• 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-0040-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim
• Z-0037-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implanta