InterStim™ X 97800 (UDI 00763000892067)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,822 adverse event reports that list this exact device (DI 00763000892067), received between Sep 17, 2024 and Sep 30, 2026 — classified as 766 injuries, 1,056 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (316 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 1,822 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break; Failure to Deliver Energy; Unstable; Low impedance

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

  MAUDE report 50950091 ↗
• InjurySep 30, 2026Failure to Deliver Energy; Migration or Expulsion of Device

  Patient problems: Urinary Incontinence

  MAUDE report 50948804 ↗
• InjurySep 30, 2026Overheating of Device

  Patient problems: Burning Sensation; Incontinence

  MAUDE report 50948696 ↗
• InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock; Insufficient Information; Pain

  MAUDE report 50948637 ↗
• InjurySep 30, 2026Electromagnetic Interference; Energy Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50948612 ↗
• MalfunctionSep 30, 2026Energy Output Problem; Insufficient Device Problem Information

  Information was received from 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 caller stated that for the past week or two they had been having issues with their handset and communicator not charging. The caller stated that it won't work, won't pick up, deactivate, or change the levels that they needed to change. The caller added that they were given a new cord, but that didn't resolve the issue. The caller did not have the equipment with them at the time of the call. The caller will call back with the equipment for further troubleshooting.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947434 ↗
• InjurySep 30, 2026Electromagnetic Interference; Failure to Deliver Energy

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for Urinary/bowel dysfunction. It was reported that ever since Wednesday when they had an MRI. They feel like they have more incontinence. Reviewed some therapy education information and redirected to their doctor. The patient (Pt) said they have not had any falls or traumas and yesterday had a swallowing test, 2 weeks ago they went to the ER due to problems with their heart, they had been on half a diuretic pill and went to one pill but when they were on one pill they are committed to being in the bathroom all the time so they had to go back to a half a pill. The patient (Pt) said they were on a diuretic before after another ER visit 2 months ago. The patient was redirected to their doctor.

  Patient problems: Incontinence; Insufficient Information

  MAUDE report 50947110 ↗
• MalfunctionSep 30, 2026Electromagnetic Interference; Energy Output Problem

  Information was received from a patient (pt) who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that they noticed today that the communicator was not responding and they didn't have a way to turn off their therapy as they pass through airport security gates. The pt mentioned the communicator would show a blinking yellow light for 60 seconds then would turn off. The pt stated they tried charging the communicator, but it didn't show any indicator lights. The pt added their programmer takes time to charge but was still working and had 67% battery life. The agent reviewed general therapy and device-use information and agent sent repair request to replace the communicator. The agent sent expedited delivery for the replacement. The agent called pt back to gather additional event information, pt answered and provided information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943077 ↗
• InjurySep 30, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that it helped their symptoms in the beginning but that did not last for more than a couple of weeks and now they are getting up 4-5 times a night or have to go every 45 minutes during the day. Pt said they met with the Medtronic rep (asked/unknown name/date) who put them on program C with cycling but when therapy came on it made their big toe curl and didn't help their symptoms, they turned therapy OFF the night before last and notice no difference in their symptoms when off or on. Pt said the doctor had the patient go for an xray and pt saw the wire looked a little crooked but the doctor didn't think it was an issue. Pt said they need to reset it again, the rep told them they would call in a couple of days but pt has waited several weeks but has not heard from the rep. Reviewed rep role, reviewed some therapy education, offered and assisted pt to use their equipment and pt was successful to change programs and increase confirming comfortable sensation. Pt to monitor the effect and continue working closely with their doctor. Offered and

  Patient problems: No Clinical Signs, Symptoms or Conditions; Sleep Dysfunction; Urinary Frequency / Polyuria

  MAUDE report 50942143 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that they just had the INS revised on Monday. The agent reviewed general therapy and device-use information. The pt changed the therapy program and increased therapy settings to a comfortable level.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942108 ↗
• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area; Insufficient Device Problem Information

  Patient problems: Ambulation or Postural Difficulties; Impaired Healing; Inappropriate Device Stimulation of Tissue; Incontinence; Insufficient Information; Pain

  MAUDE report 50938019 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Fluid Discharge; Unspecified Infection

  MAUDE report 50936874 ↗
• InjurySep 29, 2026Energy Output Problem; Electromagnetic Compatibility Problem

  Patient problems: Insufficient Information

  MAUDE report 50935465 ↗
• InjurySep 29, 2026Therapy Delivered to Incorrect Body Area; Electromagnetic Compatibility Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that the patient reported stimulation in an unexpected area. The patient stated that about a week ago, when they turned their therapy back on after surgery, they felt the stimulation mostly on their tailbone. The patient stated that they did not change the program; however, they noticed that the pocket where the INS was implanted never used to bother them, and now when they were lying on their left side, it was quite uncomfortable. The agent did not ask about the circumstances that led to the reported issue. The agent reviewed considerations for therapy optimization, general programming guidance, and general use of external devices. The agent walked the patient through connecting to the INS. The patient elected to increase the amplitude. They were able to connect to the INS and increase the stimulation. During the call, the patient felt the stimulation on their tailbone instead of their bicycle seat area. The patient was redirected to their doctor if the issue persisted.

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue

  MAUDE report 50935167 ↗
• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932641 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  Patient problems: Pain

  MAUDE report 50932314 ↗
• InjurySep 29, 2026Therapeutic or Diagnostic Output Failure

  Patient problems: Pain

  MAUDE report 50932236 ↗
• InjurySep 29, 2026Break; Failure to Deliver Energy; Energy Output Problem; Impedance Problem

  Information was received from a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (INS) for urinary dysfunction (incontinence, urgency, and/or frequency). The rep reported a 97800 issue. The lead was fractured, damaged, or broken. As a result, there was loss of stimulation. The rep stated that the programmer wouldn't allow stimulation to increase. A replacement was scheduled and they found the lead was broken at the insertion of the battery header with no obvious twiddling of the device. The damage was caused or discovered during surgery. There were impedances on all 4 electrodes prior to the case. The cause was not known. The device was replaced on (b)(6) 2026 and the issue was resolved. The rep stated that they had possession of the device and that it would be returned.

  Patient problems: Insufficient Information

  MAUDE report 50931271 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Compatibility Problem

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

  MAUDE report 50927535 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Retention

  MAUDE report 50925158 ↗
• InjurySep 28, 2026Therapy Delivered to Incorrect Body Area; Patient Device Interaction Problem

  Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue

  MAUDE report 50924361 ↗
• InjurySep 28, 2026Migration or Expulsion of Device; Insufficient Device Problem Information

  Patient problems: Micturition Urgency; Sleep Dysfunction; Urinary Frequency / Polyuria; Urinary Incontinence

  MAUDE report 50924024 ↗
• MalfunctionSep 28, 2026Energy Output Problem; Electromagnetic Compatibility Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923068 ↗
• InjurySep 28, 2026Failure to Deliver Energy; Energy Output Problem

  Patient problems: Incontinence; Pain

  MAUDE report 50917627 ↗
• MalfunctionSep 28, 2026High impedance; Insufficient Device Problem Information

  Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that an INS had a setscrew issue which caused high impedances. They attempted to remove the set screw to install a replacement but the set screw was stuck. They opened and implanted a new INS and it worked as intended. Redirected caller to Customer Services.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917409 ↗

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