InterStim™ Micro SureScan™ 97810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,757 adverse event reports that list this exact device (DI 00763000203849), received between Sep 4, 2020 and Sep 30, 2026 — classified as 802 injuries, 1,955 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (936 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 2,757 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Inappropriate/Inadequate Shock/Stimulation

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for gastrointestinal/pelvic floor therapy, urinary dysfunction/sacral nerve stim and bladder issues. It was reported that patient noticed a couple of months ago shocking sensation when they use the wireless recharger and the communicator. The pt mentioned is doesn't happen often every time but for about 3 times now when they use the external device the issue have occured. The agent reviewed general therapy and device-use information and advised the pt to turn their INS off if the shocking continued and discontinue the use of the external devices. The agent also redirected th ept to their HCP to have their INS checked.

  Patient problems: Electric Shock

  MAUDE report 50946853 ↗
• InjurySep 29, 2026Failure to Interrogate; Malposition of Device; Communication or Transmission Problem; Insufficient Device Problem Information

  Information was received from a healthcare provider (HCP) and a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor. It was reported that they were trying to put the device into MRI mode, but they were getting "Device not responding". The caller stated that the patient indicated they hadn't used the implant or external equipment for a long time. The agent walked the caller through repositioning the communicator but they continued to receive "Device not responding." The agent walked the caller through using the recharger and they described seeing open loop charging screen with the battery in the red and Antenna Locate numbers. The caller repositioned the recharger multiple times and the hi ghest value they were able to obtain was 15 and noted recharger was warm. While working with the recharger, the agent heard the patient in the background say "it hurts." The agent asked if the caller could palpate the implant and they were not able to feel it. The agent reviewed that the caller could continue to reposition the recharger to try and get higher numbers to see if they could obtain better conne

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937696 ↗
• MalfunctionSep 29, 2026Failure to Power Up; Battery Problem; Charging Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934166 ↗
• MalfunctionSep 29, 2026Display or Visual Feedback Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933466 ↗
• MalfunctionSep 28, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925362 ↗
• InjurySep 28, 2026Migration or Expulsion of Device; Unintended Collision; Energy Output Problem; Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim, gastrointestinal/pelvic floor. It was reported that the reason for the call was the patient reported they had a fall on the 14th and slipped or fell off their porch onto cement and hit their left hip to their mid back near their stimulator. They started having pain in the stimulator area so they went to the ER on the 18th and they did x-rays and said everything there checked out fine but patient was still feeling stiff. The patient did not know if it caused any device damage or migration but suspected this might be the case because the patient was in pain all night and was up half the night on a heating pad because it was the only thing that would relieve the pain. They were feeling burning pain from one hip to the other. The pain improved and they were able to sleep once turning the stimulator off but they were still feeling a sensation. The patient had an appointment with their new managing physician on October 21st at 11am in Midland, MI. The patient will leave therapy off until that time. Reviewed general risks of falls and notified fiel

  Patient problems: Burning Sensation; Muscular Rigidity; Pain; Sleep Dysfunction

  MAUDE report 50913942 ↗
• MalfunctionSep 28, 2026Battery Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction, fecal incontinence. It was reported that the reason for the call was the patient said they changed the time on the handset from New Zealand time back to the US time and when they opened the Micro My Therapy app to check the battery status they saw a message that said data has been lost contact your physician. The patient said this was what happened before (see (b)(6)). The patient was redirected to their healthcare provider to further address the issue. The patient said they didn't have a doctor they were currently working with. The patient said when this happened in the past they spoke with someone over the phone who gave them a password to get into the app where they could see all their programs and they were able to clear this message and get therapy turned back on. The patient said they would like that to be done again. Patient services reviewed the patient app vs clinician app. The patient asked for an exception and to speak with a supervisor. The agent reviewed the password could not be given to patients. The patient said they were a retired Oncol

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913858 ↗
• MalfunctionSep 17, 2026Battery Problem

  Additional information was received from the patient. They reported that they received a new device on (B)(6) 2026 that they never have to charge.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810566 ↗
• MalfunctionSep 7, 2026Unstable; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50655610 ↗
• InjurySep 4, 2026Impedance Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50617121 ↗
• MalfunctionSep 4, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610442 ↗
• MalfunctionSep 3, 2026Charging Problem; Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for gastrointestinal/pelvic floor therapy. It was reported that they are having trouble charging the recharger. All three lights are blinking green. It was noted in the repair request that there was scrolling lights on the recharger. The issue started this week. Walked caller through resetting the recharging device. The troubleshooting steps that were taken on the call did not resolve the issue. Agent asked if they store the recharger in the dock when not using it. They said they try to. Sent request to repair to replace the Wireless Recharger.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50579111 ↗
• InjurySep 2, 2026Charging 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 the patient reported for the past 5 months they felt uncomfortable since the INS was not working because their wireless recharger was not charging and was not able to recharge their INS. The patient mentioned they saw the scrolling battery lights on the recharger and it was not emitting any tones. The patient added their doctor redirected them to call the manufacturer for assistance. The agent reviewed how to attempt a hard reset, but did not resolved the issue. The agent sent repair request. On 2026-Jul-13 additional information was received from the patient. The patient stated that the replacement recharger resolved their issues.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566206 ↗
• InjurySep 2, 2026Failure to Deliver Energy; Electromagnetic Compatibility 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 for the last 2-3 months they experienced a loss of therapeutic benefit. The patient said they were bed wetting and going through at least 3 nighttime pads because they couldn't hold it anymore. The patient mentioned they were taking a medication as well, but that wasn't helping either. A couple of days ago the patient increased the amplitude on program 1 from 1.5 mA to 1.6 mA, but they didn't feel any stimulation. The patient mentioned that they just had hip surgery and were numbed "down there," so they wondered if that was why they couldn't feel stimulation. Agent reviewed stimulation expectations and considerations for therapy optimization. The patient decided to increase the amplitude and confirmed they felt comfortable stimulation. The patient will maintain stimulation level and continue to monitor symptoms.

  Patient problems: Incontinence; Urinary Incontinence

  MAUDE report 50558998 ↗
• MalfunctionSep 1, 2026Battery Problem; Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544727 ↗
• InjurySep 1, 2026Insufficient Device Problem Information; Data Problem

  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 the call was patient reported therapy issue. The patient stated that they had a fall in the driveway after receiving the implant in 2020, and the INS had been working well until this year. The patient mentioned that the communicator battery would drop over 2 to 3 hours. The patient confirmed that they charged the INS to 100% a day before. The patient confirmed that they had not consulted their HCP and stated they were making adjustments themselves with the help of their daughter, who is a nurse. The agent sent a replacement request to repair for the communicator and transferred the call to HCIT to address the handset issue. The patient was redirected to their healthcare provider to further address the issue. Upon further review, the patient mentioned that they do not know if the INS was getting weak, gradually going down, or shutting off and causing them to urinate all over themselves. The patient stated that when they connected to the INS, they saw that they were in Program 6 at 0.6

  Patient problems: Incontinence; Insufficient Information

  MAUDE report 50535903 ↗
• MalfunctionSep 1, 2026Failure to Deliver Energy

  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 they have been experiencing when the handset or the communicator goes dead the therapy shuts off. Agent explained that the therapy shouldn't shut off because the handset or communicator goes dead. Patient said they have been getting a message indicating the therapy was off, but they don't remember the message that they have received on the handset. The issue with the therapy shutting off they have been really experiencing in the last month. The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50535882 ↗
• InjuryAug 28, 2026Energy Output Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for unknown indications for use. It was reported that ever since they got their new wireless recharger, they unable to further increase their stimulation in their current program. Patient stated that every time they go to a certain level off stimulation on their current program, they were seeing the OOR message. Patient added that the OOR message was only showing on their current program and not on the other programs. Agent reviewed information and redirected the patient to their HCP to further address the issue. Patient stated that they currently don't have a HCP and refused when agent offered to send physician listing indicating they would contact the manufacturing representative (rep)  to set up an appointment. On 2026-Aug-27 additional information was received from the patient. The patient stated that they received a new implant couple of weeks ago because the previous implant failed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50497292 ↗
• InjuryAug 20, 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 patient's (pt) system was explanted today due to a malfunction. When asked, the caller had no further details about the malfunction or when it started. They also did not know the name of the healthcare provider (HCP). The agent reviewed pertinent disposal information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50357771 ↗
• InjuryAug 7, 2026Failure to Interrogate; Battery Problem; Charging Problem; Communication or Transmission Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary dysfunction/sacral nerve stim, gastrointestinal/pelvic floor. It was reported that the patient reported that they were having an issue with their handset. The patient stated that the handset screen displays the handset battery level as 100%, but they couldn't get it to show anything else and they can see horizontal and vertical lines on the screen. As a result, the patient was unable to connect to the INS as needed. The patient thought the issue might have been the charging cable for the handset because the handset wouldn't charge at one point. The patient called their doctor's office, and they called a manufacturer rep. The rep called the patient and advised the patient to call Patient Services for assistance. The patient denied dropping the handset, but they thought the screen might have gotten cracked somehow. The patient was driving at the time of the call, so they could not confirm if the screen was actually cracked. The patient said they would call back when they weren't driving to provide more detail. The patient mentioned that their INS battery was dead because it

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176872 ↗
• InjuryJul 30, 2026Failure to Deliver Energy; Unintended Collision; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  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 took a fall back in (b)(6) of last year. Since then, the patient stated that their urinary incontinence gradually became more problematic. The patient had their semi-annual appointment with their managing healthcare provider (HCP) around (b)(6), at which time they reported the worsening incontinence. Between that appointment and (b)(6), the managing HCP called a manufacturer representative (rep) to report the patient's concern and invited them to an appointment. The patient had an appointment with their managing HCP and the rep on (b)(6). During that appointment, the managing HCP's physician assistant (PA) told the patient that one of the electrodes was compromised, but the other electrodes would be enough to keep the therapy working. The rep adjusted the therapy settings until the patient felt stimulation. When the patient got home that day they didn't have to go to the bathroom for 3 hours. However, within 2 weeks of that appointment the patient no longer felt stimulation and the

  Patient problems: Incontinence

  MAUDE report 50083110 ↗
• InjuryJul 28, 2026Failure to Deliver Energy; Overheating of Device; Communication or Transmission Problem

  Information was received from a patient who was implanted with an implantable neurostimulator (INS) for fecal incontinence and gastr ointestinal/ pelvic floor. It was reported that the handset and communicator were not picking up the stimulator. They had tried for 3 days and it looked like it was not there. The last time they charged the implant was the day before yesterday. The whole thing shut off in the middle of charging. It felt like it was stabbing them or burning in just one area to the point they couldn't keep it on. They charged it to 60% and the whole machine went off. They got the handset part to come back on but now the other piece wouldn't pick up. The agent walked the caller through trying to connect to the implant. The agent confirmed they used the correct application, the communicator was unplugged, the blue light was solid, they placed the blue side of communicator against the skin vertically, the patient can palpate the stimulator, and they leaned forward. The patient got device not responding. The agent had the patient get a mirror. The patient tried lining up the communicator below the incision, above the incision, and over the incision. The patient said they sp

  Patient problems: Burning Sensation; Electric Shock; Insufficient Information

  MAUDE report 50063299 ↗
• MalfunctionJul 1, 2026Electromagnetic Interference; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR;URINARY DYSFUNCTION/SCARAL NERVE STIM. IT WAS REPORTED THAT  THE PATIENT HAD AN MRI A FEW YEARS AGO AND SINCE THEN THEY HAVE NOT BEEN ABLE TO CONNECT TO THE IMPLANT--THE CALLER NOTED THE INFO THEY GATHERED FROM THE PATIENT WAS INCOMPLETE;, IT IS UNCLEAR IF THERE IS AN ISSUE WITH SYSTEM BUT AS FAR AS CALLER KNOWS,THE PT HAD AN MRI DUE TO BREAST CANCER AND SUBSEQUENTLY COULD NOT CONNECT TO INS. THE PATIENT STOPPED USING/MAINTAINING THE SYSTEM AS FAR AS THE REP KNOWS. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE CALL, BUT THEY WERE MEETING WITH THE REPRESENTATIVE TODAY TO CHARGE THE PATIENT'S IMPLANT. THE CALLER WANTED TO REVIEW THE FUNCTION OF THE WR, AND THE AGENT REVIEWED WHAT IT SOUNDS LIKE WHEN WR CONNECTS TO INS AND REVIEWED THE SLOW GREEN PULSE. CALLER WANTED TO KNOW HOW LONG IT WOULD TAKE TO CHARGE INS SO THEY COULD CONNECT TO IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680209 ↗
• InjuryJun 30, 2026Electromagnetic Interference; Overheating of Device; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (I NS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY).IT WAS REPORTED THAT THE PATIENT HAD AN MRI IN (B)(6) 2025 (PT DOES NOT KNOW DATE) AT (B)(6) HOSPITAL. PATIENT STATES SHE HAD A BRACE OVER HER PELVIS DURING THE MRI. PATIENT STATES SHE WAS IN MRI MODE AT THE TIME AND DURING THE MRI TOWARDS THE END, PATIENT REPORTS THE BATTERY FEELING VERY HOT AND A PAINFUL ZAP DOWN THEIR LEG. PATIENT REPORTED TO THE MRI TECHNICIAN THAT THIS WAS HAPPENING. MRI TECHNICIAN RESPONDED PER PATIENT REPORT THAT THEY WERE ALMOST DONE. PATIENT REPORTED THIS TO ANOTHER MRI TECHNICIAN AND THE TECHNICIAN RESPONDED THAT THEY MIGHT HAVE BEEN ¿LEFT IN THERE TOO LONG.¿ PATIENT REPORTS SINCE MRI SHE HAS HAD INTERMITTENT PAIN AND THE BATTERY FEELING HOT AT RANDOM TIMES. ADVISED PATIENT TO TURN OFF DEVICE AND SEE PROVIDER IN OFFICE. PATIENT HAS APPOINTMENT TO BE SEEN IN OFFICE (B)(6) 2026. DEVICE TO BE REPLACED IN FUTURE, DATE UNKNOWN AND THE EVENT IS ONGOING.

  Patient problems: Alteration in Body Temperature; Electric Shock; Pain

  MAUDE report 25668205 ↗
• InjuryJun 30, 2026Difficult to Remove; Charging Problem; Insufficient 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 THERAPY. IT WAS REPORTED THAT THE IMPLANT WOULDN'T CHARGE UP AND IT DIDN'T WORK AT ALL. THE PATIENT SAID THEY WENT TO TAKE THE IMPLANT OUT BUT SOMETHING HAPPENED AND THEY COULDN'T TAKE IT OUT. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE AGENT REVIEWED USE OF ELIGIBILITY FORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25665184 ↗

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-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
• 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