INTERSTIM® II 3058Recalls & reported problems

Summary

The FDA's MAUDE database contains 990 adverse event reports that list this exact device (DI 00763000449711), received between Sep 13, 2021 and Sep 30, 2026 — classified as 411 injuries, 579 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (234 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 990 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Migration or Expulsion of Device; Overheating of Device

  Patient problems: Ambulation or Postural Difficulties; Burn(s)

  MAUDE report 50950059 ↗
• InjurySep 29, 2026Migration or Expulsion of Device; Unintended Collision

  Patient problems: Pain

  MAUDE report 50933532 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information; Unspecified Infection; Urinary Retention

  MAUDE report 50619996 ↗
• InjurySep 3, 2026Migration or Expulsion of Device; Adverse 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 and fecal incontinence. It was reported that the last few weeks they had constant pain in their right hip that kind of radiated down their leg a little bit. The patient said what they were experiencing felt similar to when they had their therapy settings changed at their healthcare provider's (HCP) office. The patient mentioned that a Physician Assistant (PA) changed their therapy settings at their HCP's office weeks ago, and the patient had not changed the therapy settings since then. The patient did not experience any falls or trauma prior to this event. The patient reported their concern to their HCP and they redirected the patient to the manufacturer. The patient was already connected to the INS at the time of the call with program B active and amplitude set to 1.1 mA. The agent reviewed considerations. The patient decided to decrease the amplitude to 1.0 mA and they thought the pain might have decreased slightly. The patient decreased amplitude to 0.9 mA, then they turned the therapy off altogether. The patient said the pain went away co

  Patient problems: Pain

  MAUDE report 50591595 ↗
• InjurySep 2, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Electric Shock

  MAUDE report 50560947 ↗
• InjurySep 1, 2026Energy Output Problem; Electromagnetic Compatibility 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 they had gone several times in the last maybe month or 6 weeks and stated they adjusted therapy but reported they still were having a great deal of leakage and stated it didn't seem like it had taken care of it completely. Patient stated it didn't seem like they were where they used to be (patient did not clarify this). Agent walked patient through steps to connect with their implant to adjust therapy settings. Patient stated their healthcare provider did not give direction on what therapy adjustments to make but directed patient to contacted Patient Services to make adjustments. Agent reviewed role of Patient Services. Agent walked patient through steps to connect with their implant. Patient confirmed therapy was on. Agent reviewed therapy considerations. Patient increased stimulation to a comfortable level. Patient will monitor symptoms. Agent redirected patient to their managing healthcare provider if issue persists. When asked for event date, patient stated they had op en heart surge

  Patient problems: Incontinence

  MAUDE report 50551634 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information; Urinary Tract Infection

  MAUDE report 50256601 ↗
• InjuryJul 29, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  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) experienced electric shocks during two MRI procedures. The pt needed the MRI because they had been in a car accident. The pt stated that the MRI technician told them the INS was MRI scan compatible but did not tell them they needed to turn off the INS prior to the MRI scan. The pt was redirected to their healthcare provider (HCP) to further address the issue.

  Patient problems: Electric Shock

  MAUDE report 50074650 ↗
• MalfunctionJul 27, 2026Battery Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50036640 ↗
• MalfunctionJun 12, 2026Failure to Interrogate; Energy Output Problem; Communication or Transmission 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 THEIR INS WAS TURNED OFF. THE PATIENT SAID THAT YESTERDAY THEY STARTED TO FEEL LIKE A VIBRATION "IN MY, IN THE AREA" AND IT GOT REALLY INTENSE, AND THEN IT WOULD QUIT AND THEN IT WOULD COME UP AGAIN AND THEN IT WOULD QUIT THEN IT COMPLETELY QUIT. PATIENT SAID THAT WHEN THEY GOT HOME, THEY TRIED TO CONNECT TO THEIR INS BUT NOTHING CAME UP. PATIENT SAID THEY GOT A MESSAGE "DEVICE COULD NOT BE FOUND". THE PATIENT SAID THEY DON'T HAVE THE EXTERNAL DEVICE WITH THEM AS OF NOW AS THEY WERE NOT HOME. AGENT REVIEWED EOS AND REDIRECTED THE PATIENT TO THEIR HEALTHCARE PROVIDER (HCP). AGENT ALSO ADVISED THE PATIENT TO CALL BACK TO CONFIRM THE MESSAGE THEY SAW.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25484948 ↗
• MalfunctionJun 9, 2026Electromagnetic Interference; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THEY WENT FOR AN MRI THE OTHER DAY AND HAD A VERY DIFFICULT TIME CONNECTING WITH THE INS. THE PATIENT SAID THEY JUST TRIED ONE LAST TIME AND IT WORKED. THE AGENT REVIEWED IF THE IMPLANT BATTERY WAS DEAD THE PATIENT WOULDN'T BE ABLE TO CONNECT WITH THE COMMUNICATOR. DURING THE CALL THE PATIENT WAS ABLE TO CONNECT WITH THE INS AND TURN THERAPY BACK ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443908 ↗
• MalfunctionJun 4, 2026Electromagnetic Compatibility Problem

  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 STATED THAT YESTERDAY THEY HAD TURNED THERAPY OFF FOR THEIR CHIROPRACTOR APPOINTMENT BECAUSE THEY USE ELECTRIC STIM ON THEIR LOWER BACK AND IT'S TOO MUCH IF IT'S ON SO THEY TURNED IT OFF. CALLED THE PATIENT BACK TO CLARIFY ELECTRIC STIM AND ASK EVENT DATE (ASKED /UNK). THE PATIENT ALSO SAID IT WAS TOO MUCH WHEN THEIR DEVICE WAS ON AND IT MADE THEM PEE THEIR PANTS, IT WAS TOO MUCH AND WHEN THEY STARTED TURNING IT OFF, THAT DID NOT KEEP HAPPENING. REVIEWED TENS/ESTIM INFORMATION.

  Patient problems: Incontinence; Insufficient Information

  MAUDE report 25399930 ↗
• InjuryJun 4, 2026Malposition of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY MENTIONED FOR THEIR FIRST IMPLANT, THE HCP WHO PUT THE FIRST SYSTEM IN, PUT THE INS IN A "WEIRD SPOT" IN THEIR BUTT CHEEK AND THEY HAD FIBROMYALGIA. THEY SAID THE PLACEMENT CAUSED THEM MORE ISSUES WITH THAT/CAUSED THEM A LITTLE BIT OF DISCOMFORT AND PAIN. PATIENT SAID THE THERAPY WORKED WELL ENOUGH AND THAT THEY WORKED WITH VARIOUS MANUFACTURER COMPANY REPRESENTATIVES WHEN THE THERAPY WASN'T HELPING WHO HAD HELPED THEM MAKE ADJUSTMENTS TO THE IMPLANTED SYSTEM (PATIENT COULD NOT RECALL REP'S NAMES BUT SAID THEY REPORTED THE THERAPY WASN'T GIVING THEM ANY RELIEF TO THE MANUFACTURER REP PROBABLY A COUPLE MONTHS AFTER THAT INITIAL IMPLANT WHEN THEY WENT INTO THE HCP OFFICE ). THE PATIENT STATED THE REPS HELPED THE PATIENT MAKE ADJUSTMENTS WITH THE INITIAL IMPLANT AND THE PATIENT WAS ABLE TO GET A LITTLE BIT OF RELIEF, BUT NOT AS MUCH AS THEY THOUGHT THEY WOULD GET. PATIENT SAID BECAUSE THE IMPLANT WAS IN THAT "WEIRD SPOT" AND BECAUSE THEY DIDN'T LIKE HOW THEIR PREVIOUS HCP HAD SPOKEN OF THEIR SURGERY WITH ANOTHER PATIENT WHO ALSO

  Patient problems: Insufficient Information

  MAUDE report 25398872 ↗
• InjuryJun 3, 2026Break; Unintended Collision

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGE INCONTINENCE, URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS TO GET MRI INFORMATION. THE CALLER INDICATED THAT THE PATIENT REPORTED THAT THE IMPLANTED LEAD MAY BE BROKEN. THE PATIENT WAS IN A CAR ACCIDENT AT SOME POINT AND PLANNED TO HAVE THE LEAD FIXED AT A PROCEDURE IN (B)(6) 2026. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TECHNICAL SERVICES REVIEWED MRI INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383800 ↗
• MalfunctionJun 2, 2026Electromagnetic Interference; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER AND 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 PATIENT NEEDED TO HAVE AN MRI BUT THE HANDSET DID NOT WORK AND THE BATTERY DID NOT HOLD A CHARGE. THE CALLER DID NOT KNOW WHEN THE HANDSET STOPPED WORKING. THE PATIENT WAS REPORTED TO TELL THE CALLER THAT THEY HAD BEEN SCANNED BEFORE, BUT THEY DID NOT TELL ANYONE ABOUT THEIR STIMULATOR. THE AGENT ADVISED THE PATIENT TO CALL PATIENT SERVICES. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF CALL. THE PATIENT CALLED AND ASKED ABOUT MRI. THE PATIENT SAID THEY NEEDED AN MRI OF THEIR BACK AS THEY NEEDED SURGERY. THE PATIENT SAID THAT THE IMPLANT DIDN'T WORK AND HADN'T WORKED IN A LONG TIME. THE PATIENT SAID THEY ONLY HAD THE COMMUNICATOR AND DIDN'T HAVE THE HANDSET. THE AGENT REVIEWED DEVICE INFORMATION. THE AGENT REVIEWED MRI GUIDELINES AND LOST/STOLEN PROCESS. THE PATIENT SAID THEY HADN'T SEEN THEIR MANAGING DOCTOR FOR 5 YEARS HOWEVER THEY WOULD CALL THEM AND ASK TO HAVE THE SYSTEM REMOVED. THE PATIENT SAID THEY HAD SEVERAL MRIS PRIOR TO NOW WITHOUT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359107 ↗
• InjuryJun 1, 2026Battery Problem; Insufficient Device Problem Information

  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 THEY WENT A LONG TIME WITHOUT HAVING THE DEVICE BECAUSE ITS BATTERY WAS TOO LOW. THEY HAD AN APPOINTMENT WITH HEALTHCARE PROVIDER (HCP) AND THEY NOTICED IT WASN'T WORKING AND ORDERED TO GET IT REPLACED. AGENT ASKED WHEN THEY FIRST NOTICED IT WAS RUNNING OUT OF BATTERY AND PATIENT SAID THEY DON'T REMEMBER THINGS WELL IF THEY DON'T WRITE THEM DOWN. THEY'VE BEEN HAVING WATERY FECES EVEN BEFORE THEY REPLACED THEIR PREVIOUS DEVICE.

  Patient problems: Fecal Incontinence

  MAUDE report 25354405 ↗
• InjuryMay 28, 2026Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER ON 2026-APR-16 REGARDING 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 RECEIVED A REPLACEMENT HANDSET AND COMMUNICATOR FOR A LOST DEVICE. THEY WERE TRYING TO CONNECT TO THE INS AND WERE UNABLE TO CONNECT. PRIOR TO CALLING, THE CALLER GOT A MESSAGE THAT THE COMMUNICATOR NEEDED TO BE UPDATED, THE SCREEN SAID UPDATE IN PROGRESS. THE COMMUNICATOR UPDATE COMPLETED DURING THE CALL. THEY OPENED THE APPLICATION AND THE HANDSET CONNECTED TO THE COMMUNICATOR. THE CALLER ATTEMPTED TO CONNECT TO THE INS AND GOT THE NO DEVICE FOUND MESSAGE. THE CALLER TRIED TO CONNECT TO THE INS WITH THE COMMUNICATOR IN SEVERAL DIFFERENT LOCATIONS BUT THE DEVICE DID NOT FIND THE INS. THE PATIENT REPORTED THAT SOMETIMES THEY FELT STIMULATOR BUT WERE NOT FEELING STIMULATION AT THE TIME OF THE CALL, LATER IN THE CALL THEY SAID THAT THEY WERE FEELING STIMULATION. THE CALLER USED A SECOND PROGRAMMER AND THE CLINICIAN APP FOUND THE INS, DISPLAYED THE SERIAL NUMBER OF THE INS. WHEN THE CALLER SELECTED THE DEVIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319186 ↗
• InjuryMay 27, 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 PROBABLY IN THE LAST YEAR OR SO THEY STARTED HAVING BLADDER LEAKAGE AGAIN. THE PATIENT MENTIONED THAT THEY WERE BLIND IN THEIR LEFT EYE DUE TO MELANOMA, WHICH RESULTED IN THEM TRIPPING AND FALLING A COUPLE OF TIMES. THE PATIENT SAID THEY FELL ON THEIR BUTT, AND CONFIRMED THE FALLS HAPPENED PRIOR TO THE EVENT. THE PATIENT MET WITH THEIR HEALTH CARE PROVIDER (HCP) TO REPORT THE THERAPY ISSUE BUT DIDN'T INFORM THE HCP ABOUT THE FALLS. AGENT REVIEWED ROLE OF PATIENT SERVICES AND ADVISED THE PATIENT TO DISCUSS OPTIONS WITH THEIR HCP. THE PATIENT SAID THEY SEE THEIR MANAGING HCP TWICE NEXT WEEK, AND MONDAY WILL BE THE FIRST APPOINTMENT OF THE TWO. THE PATIENT SAID THEY WILL MENTION THAT THEY FELL ON THEIR BUTT WHEN THEY HAVE THEIR APPOINTMENT ON MONDAY (B)(6) 2026. THE PATIENT WAS REDIRECTED TO THEIR HCP TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2026-MAY-04. THEY REPORTED THAT THE PATIENT MENTIONED BLADDER LEAKAGE AGAIN ON THEIR PREVIOUS IMPLANT LEA

  Patient problems: Incontinence

  MAUDE report 25306442 ↗
• InjuryMay 26, 2026Battery Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR, URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THE CALLER SAID THE PATIENT WAS IN THE HOSPITAL AND NEEDED AN MRI OF THEIR BRAIN. THE CALLER SAID THEY WOULDN'T DO THE MRI BECAUSE THEY SAID THE INTERNAL BATTERY WAS LOW. THE CALLER STATED THEY TESTED THE DEVICE AT THE HOSPITAL WHEN THE PATIENT WAS IN THEIR ROOM AND THEY COULD PULL UP THE PROGRAM ON THE HANDSET. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE CALL, SO TROUBLESHOOTING COULD NOT BE PERFORMED. THE CALLER MENTIONED THAT THE DEVICE DIDN'T WORK ENOUGH AND DIDN'T HELP THE PATIENT ENOUGH THAT THEY WANTED TO DO THE SURGERY AGAIN TO REPLACE THE STIMULATOR. THE CALLER WAS GOING TO CALL BACK WHEN WITH PATIENT TO SEE IF THEY CAN PUT THE DEVICE IN MRI MODE. THE CALLER CALLED BACK WITH THE EXTERNAL DEVICES. PATIENT SERVICES REVIEWED EXTERNAL DEVICE USE AND THE CALLER WAS ABLE TO CONNECT TO THE INS SUCCESSFULLY AND ACTIVATE MRI MODE. ADDITIONAL INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER AND THE PATIENT. THE PATIE

  Patient problems: Insufficient Information

  MAUDE report 25283545 ↗
• InjuryMay 26, 2026Break; Failure to Interrogate; Unintended Collision; Battery Problem; Communication or Transmission Problem; Impedance Problem; Insufficient Device Problem Information

  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 THOUGHT SOMETHING WAS NOT WORKING, THEY WERE SWELLING UP PRETTY BAD, THEY COULDN'T GO TO THE BATHROOM, THEY HAD GAINED 4 POUNDS SINCE FRIDAY AND NORMALLY THEY DID NOT HAVE FLUID RETENTION BUT THEIR FEET WERE SO SWOLLEN LAST NIGHT THEY COULD HARDLY WALK. THE PATIENT SAID THEY TOOK A BAD FALL YESTERDAY AND HIT THEIR HEAD. THE PATIENT ALSO SAID ON FRIDAY THEY WERE TRYING TO GET THEIR EQUIPMENT CONNECTED AND THEY NEVER WOULD CONNECT AND ONE MESSAGE FINALLY CAME UP THAT SAID THE COMMUNICATION WAS IN DEFAULT. THE PATIENT SAID THE COMMUNICATOR LIGHT NEVER WENT OFF THE RED, THEN IT TURNED GREEN WHEN THEY TOOK THE CORD OUT. THE AGENT OFFERED TO ASSIST THE PATIENT TO TROUBLESHOOT, BUT THE PATIENT SAID THEY DID NOT HAVE THE EQUIPMENT WITH THEM DURING THE CALL. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE PATIENT SAID THEY MOVED AND NO LONGER SAW THEIR OLD DOCTOR THEY SAW A NEW DOCTOR BUT COULD NOT REMEMBER THEIR N

  Patient problems: Ambulation or Postural Difficulties; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema; Urinary Retention; Weight Changes

  MAUDE report 25280209 ↗
• MalfunctionMay 22, 2026Battery Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URINARY URGE INCONTINENCE. IT WAS REPORTED THAT THE CALLER REPORTED THE PATIENT SEEING "LOST ALL DATA" MESSAGE YESTERDAY. THE CALLER INQUIRED ABOUT GETTING A MANUFACTURER REPRESENTATIVE (REP) TO INTERROGATE THE NEUROSTIMULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25261084 ↗
• MalfunctionMay 19, 2026Unintended Collision; Positioning Problem; 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 THEY HAD A BAD CAR ACCIDENT A LITTLE OVER 3 WEEKS TO A MONTH AGO AND WERE IN BED A LOT SO THEY DID NOT KNOW IF MAYBE THAT KNOCKED OUT THE IMPLANT OR THE LEAD WIRE. AFTER THE ACCIDENT THEIR LOWER BACK HAS BEEN HURTING REAL BAD AND THEY NOTICED THEY FELT A THING STICKING OUT IN THEIR BACK THAT WAS SORE. PATIENT ALSO REPORTED THEY HAVE BEEN TRYING TO GET AN MRI NUMEROUS TIMES AND THE LAST TIME THEY WENT ON FRIDAY THEY COULD NOT GET THE IMPLANT TURNED OFF. REVIEWED HOW TO ACTIVATE MRI MODE AND PATIENT WAS ABLE TO SUCCESSFULLY CONNECT TO IMPLANTED NEUROSTIMULATORS BUT WHEN THEY ACTIVATED MRI MODE THE ENCOUNTERED "MISSING IMPLANT INFORMATION" MESSAGE. REVIEWED MRI PROGRAMMING IS LOST WHEN THE PROGRAMMER IS REPLACED AND PATIENT WILL NEED TO FOLLOW UP WITH MANAGING PHYSICIAN'S OFFICE TO UPDATE MRI PROGRAMMING. PATIENT INDICATED THEY ALREADY LEFT A MESSAGE WITH THEIR PHYSICIAN'S OFFICE.

  Patient problems: Discomfort; Pain

  MAUDE report 25212205 ↗
• MalfunctionMay 18, 2026Loss of Data

  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 THEY WERE TOLD BY THE MANUFACTURER REPRESENTATIVE (REP) THAT THE REP WAS GOING TO ADD SOME PROGRAMS AFTER THE REVISION THEY HAD LAST MONDAY, BUT THEY ENDED UP LOSING ALL THE OTHER PROGRAMS. AGENT REDIRECTED THE PATIENT TO THEIR DOCTOR TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203479 ↗
• InjuryMay 18, 2026Migration or Expulsion of Device

  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 A REVISION BECAUSE THE LEAD SLIPPED AND WAS NO LONGER IN ITS PLACE, WHICH STARTED SINCE SOME TIME IN (B)(6) OF 2025. AGENT REDIRECTED THE PATIENT TO THEIR DOCTOR TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203362 ↗
• InjuryMay 11, 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 THERAPY. IT WAS REPORTED THAT PROBABLY WITHIN THE LAST 6 MONTHS THEY NOTICED THE THERAPY DIDN'T SEEM TO BE HELPING THEM ANYMORE AND "IT WAS ACTUALLY GETTING UNCOMFORTABLE." AS A RESULT, THE PATIENT DECIDED TO HAVE THE INS AND LEAD REMOVED ON (B)(6) 2026. THE AGENT DOCUMENTED THE REPORTED EVENT. NO FURTHER ACTION WAS TAKEN BY PATIENT SERVICES.

  Patient problems: Discomfort

  MAUDE report 25141582 ↗

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