INTERSTIM® 3058 (UDI 00613994913654)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23,065 adverse event reports that list this exact device (DI 00613994913654), received between Mar 25, 2013 and Sep 30, 2026 — classified as 6 deaths, 10,815 injuries, 12,244 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4,831 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 23,065 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Break; Electromagnetic Interference; Unintended Collision; Insufficient Device Problem Information

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

  MAUDE report 50952878 ↗
• MalfunctionSep 30, 2026Battery Problem; Loss of Data; Electromagnetic Compatibility Problem; Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for gastrointestinal/ pelvic floor, urinary dysfunction/sacral nerve stim It was reported that  they noticed today that they cannot access their therapy settings. The patient mentioned that they had a heart procedure earlier today and had the INS turned off right after the procedure when they were trying to access their therapy settings to turn the INS back on when they encountered a message, 'The data has been lost. Please contact your clinician." The agent reviewed general therapy and device-use information and redirected the pt to their HCP to check the status of their INS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947519 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for gastrointestinal/pelvic floor therapy. It was reported that they didn't have a managing physician to monitor their implant. They reported they still had the InterStim implant; however, they would like to have it removed as about a month ago they said that it started to hurt. The patient said they would contact their healthcare provider (HCP) to discuss. The agent told the patient to provide an update once their InterStim devices were removed. The agent documented the event, no further action taken by Patient Services.

  Patient problems: Pain

  MAUDE report 50946577 ↗
• InjurySep 30, 2026Migration or Expulsion of Device; Communication or Transmission Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for Gastrointestinal pelvic floor. It was reported that the INS was hurting their hip and described it as 'spiraling out of control' and it started about 3 days ago. The patient mentioned that they don't know whether it's about the control or something that moves inside. The patient mentioned that they went to Mexico and was redirected by their healthcare provider (HCP) to call MDT. The agent educated patient on general use of external devices. The agent walked patient through connecting to INS. The agent instructed the patient to connect to the implant with and without the antenna. The patient saw the same stimulation screen for poor communication. The agent instructed to reposition programmer try again; however, they saw possible EOS settings. The issue was not resolved through troubleshooting. The patient was redirected to their healthcare provider to arrange INS replacement and further address the issue.

  Patient problems: Insufficient Information; Pain

  MAUDE report 50944406 ↗
• 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 dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor. It was reported that had to have INS removed because it started hurting and burning their leg.

  Patient problems: Burning Sensation; Pain

  MAUDE report 50937363 ↗
• MalfunctionSep 29, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932523 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932048 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 50931959 ↗
• InjurySep 29, 2026Failure to Interrogate; Migration or Expulsion of Device; Vibration; Communication or Transmission Problem; Insufficient Device Problem Information

  Patient problems: Sleep Dysfunction

  MAUDE report 50927561 ↗
• MalfunctionSep 28, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924316 ↗
• InjurySep 28, 2026Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor. It was reported that the device was removed because it stopped working.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919094 ↗
• MalfunctionSep 28, 2026Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917637 ↗
• MalfunctionSep 28, 2026Electromagnetic Interference; Battery Problem

  Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor. It was reported that the caller reported seeing a message on the handset that said 'data lost, internal device has lost all data, contact your clinician.' Caller stated they were with the patient trying to put the device into MRI mode this morning when the message appeared. Caller confirmed there were no falls or trauma to the area prior to seeing the message. Caller also mentioned that the patient had a CT scan when they arrived at the hospital, but they did not have the handset with them at the time of that scan. The issue was not resolved through troubleshooting. Agent reviewed MRI scanning guidelines and suggested the patient follow up with their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915634 ↗
• InjurySep 28, 2026Disconnection; Migration or Expulsion of Device; Unintended Collision; Therapy Delivered to Incorrect Body Area; Material Deformation; Insufficient Device Problem Information

  Patient problems: Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions; Pain; Sleep Dysfunction

  MAUDE report 50915612 ↗
• InjurySep 28, 2026Therapy Delivered to Incorrect Body Area

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor. It was reported that the patient (pt) noticed that they were still incontinent. The pt mentioned their symptoms gotten worse this year (asked, unknown specific date). The pt described their situation as follows "pee was running on them" according to the pt. The pt stated that they know their INS was still working since they still can feel the stimulations' sensation going down to their toes. The pt added their previous healthcare provider (HCP) relocated and they were now seeing a new Urologist. The agent reviewed general therapy and device-use information, but the pt mentioned their external devices both the communicator and the programmer got lost. The agent redirected the pt to SunMed to process the missing device replacement.

  Patient problems: Inappropriate Device Stimulation of Tissue; Incontinence; Insufficient Information; Urinary Incontinence

  MAUDE report 50914466 ↗
• MalfunctionSep 28, 2026Battery Problem

  Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy. It was reported that there was a POR message and the battery level was "OK."  The reason for removal was "patient's request."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913994 ↗
• InjurySep 28, 2026Break; Insufficient Device Problem Information

  Information was received from a patient with an implanted neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy. It was reported that the reason for call was for patient to inquire about compatibility of INS with TMS psychotherapeutic treatment. Agent reviewed guidelines. Patient asked if it would make a difference in compatibility if one of the leads was broken. They reported event date as "probably like a year ago maybe." Patient stated that they didn't know how the lead broke because they were not aware of it. Patient said that they went to see their healthcare provider and the healthcare provider told the patient that the lead wasn't working and to leave the device turned off until they could get it replaced. Patient mentioned that they were scheduled for surgery, but they couldn't get a ride or any way to get to the surgery at this time. Patient also commented that they couldn't get an MRI at all. Agent reviewed MRI scanning guidelines. Patient asked how they could tell if device was at EOS. Agent reviewed meaning of EOS with the patient and suggested they could try to connect with their external controller. The patient was r

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910758 ↗
• MalfunctionSep 25, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50900764 ↗
• InjurySep 8, 2026Overheating of Device; Inappropriate/Inadequate Shock/Stimulation

  Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stimulation/gastrointestinal/pelvic floor It was reported that  the patient is getting a zapping sensation, the caller also described the sensation as burning, painful, and random sharp pain. The caller contacted the managing HCP, and they said that they would not have a rep available at their facility until Oct 2026. The caller was not with the patient. TSS reviewed options for turning therapy off.

  Patient problems: Burning Sensation; Electric Shock; Pain

  MAUDE report 50674046 ↗
• InjurySep 8, 2026Insufficient Device Problem Information

  Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor. It was reported that the operative report says there is a breakdown (mechanical) of the implanted electronic neurostimulator.. the system was removed and replaced on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50672768 ↗
• MalfunctionSep 8, 2026Battery Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for gastrointestinal/ pelvic floor and urinary dysfunction/sacral nerve stim. It was reported that they had already found their lost devices, and when they tried to connect to the INS, they saw the POR message and could not clear it. Agent redirected them to the healthcare provider (HCP) to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669552 ↗
• InjurySep 7, 2026Break; Difficult to Remove

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50650828 ↗
• InjurySep 4, 2026Inappropriate/Inadequate Shock/Stimulation; Battery Problem

  Patient problems: Discomfort; Electric Shock

  MAUDE report 50612338 ↗
• MalfunctionSep 4, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50612230 ↗
• MalfunctionSep 3, 2026Battery Problem; Electromagnetic Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50593627 ↗

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