InterStim™ Micro SureScan™ MRI 97810Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00763000596736), received between Jun 10, 2024 and Sep 4, 2026 — classified as 10 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Delayed Charge Time; Charging Problem; Patient Device Interaction Problem

  Additional information was received from a manufacturer representative (rep). The rep indicated that the field team was not contacted by the patient nor the healthcare provider (HCP) regarding this matter. They were not previously made aware of this event. They would reach out to the patient to establish contact and determine the reason for the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619604 ↗
• MalfunctionSep 4, 2026Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50618764 ↗
• InjurySep 1, 2026Malposition of Device

  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 the patient's wife said that has been sick for the last year and lost a lot of weight and the internal part of the generator was sticking out of their skin so the healthcare provider had to lower and reposition the implant. When asked, patient said that this occurred several months ago, within the past year by the same doctor.

  Patient problems: Weight Changes

  MAUDE report 50549904 ↗
• MalfunctionJun 29, 2026Electromagnetic Interference; Failure to Deliver Energy; No Device Output

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION, URINARY URGENCY. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THAT THE PATIENT REPORTED A THERAPY ISSUE. THE PATIENT MENTIONED THEY HAD BEEN GOING TO THE BATHROOM MORE FREQUENTLY AND URINATING MORE OFTEN. THE PATIENT STATED THEY WENT TO A BERRY FARM AND HAD TO TURN OFF THE THERAPY WHEN PASSING THROUGH A METAL DETECTOR; HOWEVER, THEY WERE NOT ABLE TO TURN THE THERAPY BACK ON AFTERWARD. THE AGENT INSTRUCTED THE PATIENT TO CONNECT TO THE INS. THE PATIENT WAS ABLE TO CONNECT TO THE INS AND TURN THE THERAPY BACK ON. HOWEVER, WHEN THE THERAPY WAS TURNED BACK ON, THE PATIENT EXPERIENCED SUDDEN AND EXTREME PAIN. THE AGENT INSTRUCTED THE PATIENT TO DECREASE THE STIMULATION, AND THE PATIENT CONFIRMED THEY FELT COMFORTABLE AFTER THE ADJUSTMENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER IF SYMPTOMS PERSIST.

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 25660480 ↗
• MalfunctionMay 21, 2026Delayed Charge Time

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE 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 THE CALLER REPORTED IT WAS TAKING A LONG TIME TO CHARGE THE IMPLANTED NEUROSTIMULATOR. THE CALLER MET WITH THE PATIENT IN OFFICE AND CONFIRMED THE RECHARGING SPEED WAS SET TO FAST, THE PATIENT DID NOT NOTICE A LARGE AMOUNT OF HEAT, AND THE RECHARGER CONNECTED QUICKLY TO THE IMPLANT AND WAS CHARGING WITH EXCELLENT CONNECTION. HOWEVER, IT TOOK 30 MINUTES TO INCREASE FROM 40% TO 50% IN OFFICE. THE CALLER CONFIRMED THEY WERE ABLE TO CONNECT WITH THE CLINICIAN APP WITHOUT ISSUE, IMPEDANCES WERE NORMAL AND USAGE DATA INDICATED PATIENT HASN'T MADE ANY PROGRAM CHANGES, ONLY INCREASED STIM BY 0.1 MA IN THE LAST MONTH. THE CALLER STATED THAT THERE WAS NO RECHARGING DATA AVAILABLE WHATSOEVER. THE CALLER STATED PATIENT CHARGED WEEKLY WHEN THE IMPLANT WAS ABOUT 40% AND IT TOOK AROUND 2 AND A HALF HOURS. THE CALLER MENTIONED HAVING TO TROUBLESHOOTING MICRO IMPLANTS IN THE PAST. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE AGENT REVIEWED IT WAS UNCLEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241978 ↗
• MalfunctionMay 14, 2026Malposition of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND FECAL INCONTINENCE. IT WAS REPORTED THAT THEY DON'T THINK THE DEVICE HAS EVER HELPED WITH THEIR SYMPTOMS SINCE IT WAS IMPLANTED. CALLER STATED THEY HAVE TRIED ALL 7 PROGRAMS AND NONE WERE SUCCESSFUL. CALLER STATED IN ADDITION TO THAT THEY WERE GIVE 4 MORE (A-D) AND THEY DIDN'T HELP EITHER. CALLER STATED THEY HAVE NOT CHANGED THE SETTINGS IN QUITE A WHILE. CALLER STATED THEY WENT TO SEE A DIFFERENT COLORECTAL DOCTOR WHO SAID THAT THE IMPLANTING SURGEON MUST HAVE PLACED IT IN THE WRONG LOCATION ALONG THE SPINE; IT IS ON THE S4 INSTEAD OF S3 (WHICH THEY THOUGHT ALL THE STUDIES WERE DONE ON S3). THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 25175134 ↗
• MalfunctionMar 25, 2026Electromagnetic Interference; Overheating of Device; Inappropriate/Inadequate Shock/Stimulation; Unstable; Delayed Charge Time; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGE INCONTINENCE, URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THE CALL WAS FROM A PATIENT REGARDING AN IMPLANTED NEUROSTIMULATOR (INS). THE PATIENT SAID THAT WITHIN ONE MONTH OF IMPLANT, THE IMPLANT FLIPPED AND THE NEUROSTIMULATOR HAD HEALED AT AN ANGLE. THE PATIENT SAID THAT IT FELT LIKE THE LEFT SIDE OF IMPLANT WAS POKING UP AND THE OTHER END WAS POKING IN THEIR HIP. THE PATIENT SAID THEY HADN'T NOTICED ANY CHANGES TO THE IMPLANT SITE SINCE RECEIVED. THE PATIENT SAID THAT IT ALSO OOZED WHILE HEALING. THE PATIENT SAID THEY DID NOTIFY THEIR MANAGING PHYSICIAN AND WAS TOLD THAT IF THE NEUROSTIMULATOR STARTED TO HURT TO CONTACT THE DOCTOR. THE PATIENT SAID THAT IT DIDN'T HURT HOWEVER THEY SAID THAT IT TOOK A REAL LONG TIME TO RECHARGE MOST OF THE TIME AND THEY HAD TO CONSTANTLY REPOSITIONING AND SOMETIMES IT DIDN'T TAKE AS LONG TO RECHARGE. THE PATIENT SAID THAT THEY TYPICALLY HAD TO LAY ON IT, REPOSITION AND NOT MOVE AT ALL. THE PATIENT SAID THEY FELT FOR THE ANGLE AND TRIED TO POSITION THE RECHARGER OVER THAT. THE PATIENT SAID THEY USED A VERY LOW SETTING AND TYPICALLY RECHA

  Patient problems: Electric Shock; Fluid Discharge; Insufficient Information; Scar Tissue; Swollen Lymph Nodes/Glands

  MAUDE report 24689577 ↗
• MalfunctionMar 18, 2026Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION, URGE INCONTINENCE. IT WAS REPORTED THAT THE PATIENT SAID THAT THEY NOTICED A RETURN OF BLADDER SYMPTOMS OVER THE LAST 48 HOURS AND DECIDED TO CHECK AND START A RECHARGE SESSION. THE PATIENT SAID THEY FELT THE CHANGE IN THEIR BODY YESTERDAY AND NOTICED THAT THE NEUROSTIMULATOR WAS DEPLETED. THE PATIENT SAID THAT WHEN THEY STARTED A RECHARGE SESSION TODAY THEY RECEIVED A DIFFERENT SCREEN WITH A HIGH AND LOW NUMBER. REVIEWED MEANING OF OPEN LOOP SCREEN. THE PATIENT STOPPED THE RECHARGE SESSION DURING THE CALL AS THEY REPORTED IT HAD STARTED TO SHOCK THEM, SO THE PATIENT CHANGED THE SPEED OF RECHARGING HOWEVER THEY SAID THAT IT WAS STILL SHOCKING THEM SO THEY STOPPED THE RECHARGE SESSION, SAID THAT REACHED 80%. THE PATIENT STATED THAT THE SHOCKING WAS OCCURRING AT THE IMPLANT SITE AND THAT THE SENSATION DIDN'T CHANGE AFTER ACHIEVING A FULL CONNECTION. THE PATIENT SAID THAT THEY STARTED THIS RECHARGE SESSION ABOUT 30 MINUTES AGO. WITH A REMINDER, THE PATIENT MANUALLY TURNED STIMULATION ON.

  Patient problems: Electric Shock

  MAUDE report 24632699 ↗
• InjuryFeb 20, 2026Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DISFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT THE RIGHT IMPLANTED SYSTEM WAS REMOVED BECAUSE IT WAS STICKING ON THEIR BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403288 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT HAD A LOT OF PROBLEMS AFTER IMPLANT WITH SKIN HEALING AND HAD AN INFECTION FOR ALMOST 3 MONTHS AND THE DOCTOR WAS NOT SURE IF PATIENT WAS GOING TO BE ABLE TO GET PAST THAT OR IF THEY WOULD HAVE TO TAKE THE STIMULATOR OUT. THEIR INFECTION EVENTUALLY RESOLVED AND PATIENT WAS ABLE TO KEEP THE DEVICE.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 24114904 ↗
• MalfunctionJan 16, 2026Failure to Deliver Energy; Delayed Charge Time; Charging Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THEY WERE HAVING TO CHARGE EVERY OTHER DAY AND IT WAS TAKING OVER AN HOUR TO CHARGE WITH EXCELLENT CONNECTION. CALLER STATES IT USED TO TAKE 20 MINUTES TO CHARGE. CALLER STATES SLOWLY SINCE IMPLANT, EVERY SINGLE WEEK IT WAS GETTING MORE AND MORE DIFFICULT TO CHARGE AND TAKING LONGER TO CHARGE. THEY USED TO CHARGE ABOUT EVERY 3-4 DAYS AND NOW IT WAS ABOUT EVERY OTHER DAY. CALLER STATED THE LAST TIME SETTINGS WERE CHANGED WAS WITH THE REP AND IT WAS (B)(6) 2025. THE SETTINGS WEREN'T REALLY WORKING SO PATIENT WENT BACK TO THE PROGRAM THAT HELPED WITH THE BOWEL THE CONSTIPATION THE ADJUSTMENTS FOR THE BLADDER DID NOT DO TOO MUCH. CALLER STATES PATIENT WAS CURRENTLY ON PROGRAM 5 AT 7.5 SINCE AROUND OCTOBER OR NOVEMBER. THE REP ALWAYS DOES THE PROGRAMMING. CALLER STATED WHEN THE CHARGE LEVEL GETS DOWN TO 10% THEN THE THERAPY SHUTS OFF. CALLER STATED THAT LAST NIGHT IT TOOK ALMOST AN HOUR AND A HALF TO CHARGE IT FROM 10%. PATIENT HAD NOT SEEN DOCTOR SINCE (B)(6) 2025 AND HAVING TO CHARGE EVERY OTHER DAY WAS

  Patient problems: Insufficient Information

  MAUDE report 24092264 ↗
• MalfunctionDec 8, 2025Display or Visual Feedback Problem; Battery Problem; Display or Visual Feedback Problem; Battery Problem

  ON 2026-MAR-24 ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT STATED THAT THE CAUSE OF THE POR WAS UNKNOWN, BUT LIKELY DUE TO THEM NOT RECHARGING THE INS IN A TIMELY MANNER WHICH RESULTED IN THE BATTERY NOT BEING ACTIVATED. THE PATIENT STATED THAT DURING THEIR CALL TO CUSTOMER SUPPORT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750738 ↗
• MalfunctionDec 8, 2025Intermittent Continuity; Electromagnetic Interference; Overheating of Device; Data Problem; Intermittent Continuity; Electromagnetic Interference; Overheating of Device; Data Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE CAUSE OF THE DEVICE HEATING UP HAD NOT BEEN DETERMINED AND WHAT MOST LIKELY CAUSE OR CONTRIBUTED TO THIS ISSUE THAT IS UNKNOWN. THE PATIENT REPORTED FEELING WARMTH AND HEAT AT THE SITE OF THEIR DEVICE WHEN THEY WERE IN CLOSE PROXIMITY TO A SPECIFIC TYPE OF MACHINE THAT THEY USED AT WORK. THEY HAD THIS DEVICE FOR THEIR BLADDER AND BOWEL. WHEN ASKED WHAT STEPS WERE YOU WERE OR WILL BE TAKEN TO RESOLVE THIS ISSUE THEY REPORTED THAT THE PATIENT CAME TO THEM ON 2025-DEC-03 AND THEY CHECKED THE DEVICE AND THEY HAD NORMAL IMPEDANCE AND THEY WAS FEELING STIMULATION IN THE CORRECT PLACE THEY WERE NOT CURRENTLY HAVING PAIN AS THEY WERE OBVIOUSLY NOWHERE NEAR THIS MACHINE THAT THEY USED AT THEIR WORKPLACE. THEY DID CONFIRM THAT EVERYTHING WAS WORKING CORRECTLY ON THEIR DEVICE AND THE DEVICE ITSELF HAD NOT BEEN DAMAGED BUT THEY HAD DECIDED THAT IT WOULD BEST FOR THE PATIENT TO WORK FURTHER FROM THIS MACHINE AND BE ASKED OR TO ASK FOR EMPLOYERS TO MOVE THEM TO A DIFFERENT DEPARTMENT OR A DIFFERENT MACHINE TO USE. WHEN ASKED ABOUT THE CAUSE OF THE SIMULATION CHANGING TURNING ON AND OFF DETERMINED,

  Patient problems: Insufficient Information

  MAUDE report 23743091 ↗
• MalfunctionOct 31, 2025Failure to Deliver Energy; Battery Problem; Failure to Deliver Energy; Battery 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 THE PATIENT USUALLY CHARGED THEIR INS TWICE A WEEK AND AT THE START OF THE CHARGING SESSION THE INS WAS USUALLY DOWN TO 30%. THE PATIENT SAID THE LAST TWO TIMES THEY CHARGED THE IMPLANT; THE BATTERY WAS ONLY DOWN TO 90%. THE PATIENT SAID THEY GOT THE DEVICE BECAUSE THEY WERE URINATING AND STOPPING. THE PATIENT ALSO HAD A BURNING SENSATION IN THEIR BUTT AND DOWN THE BACK OF THEIR LEGS, AND THEIR UROLOGIST SAID THE DEVICE MIGHT HELP WITH THE BURNING, WHICH IT DID. THE PATIENT SAID SINCE THE INS BATTERY HAD NOT BEEN DEPLETING LIKE USUAL, THE BURNING SENSATION RETURNED BUT THEIR URINARY CONTROL WAS STILL GOOD. THE PATIENT WAS INSTRUCTED HOW TO CHECK THE INS WITH THE MICRO MYTHERAPY APPLICATION. THE PATIENT SAW A POWER ON RESET (POR) MESSAGE. THE PATIENT WAS ABLE TO CLEAR THE POR MESSAGE AND TURN STIMULATION ON. THE PATIENT SAID THE INS BATTERY DID NOT RECENTLY DEPLETE. THE PATIENT INCREASED STIMULATION TO A COMFORTABLE LEVEL. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE

  Patient problems: Burning Sensation; Insufficient Information

  MAUDE report 23442498 ↗
• MalfunctionOct 27, 2025Failure to Interrogate; Improper or Incorrect Procedure or Method; Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Improper or Incorrect Procedure or Method; Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE CAUSE OF NEVER BEING ABLE TO CONNECT TO DEVICE SINCE IMPLANT WAS UNKNOWN. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23395773 ↗
• MalfunctionOct 27, 2025Delayed Charge Time; Charging Problem; Communication or Transmission Problem; Delayed Charge Time; Charging Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). THEY REPORTED THAT THEY ADVISED THE PATIENT TO CALL PATIENT SERVICES. THE PATIENT MENTIONED THAT THEY CAN GET A GOOD CONNECTION AT TIMES, BUT THE CONNECTION ONLY LASTS FOR ABOUT A MINUTE BEFORE THE RECHARGER LOSES CONNECTION ALTOGETHER AND STARTS BEEPING/SEARCHING AGAIN. THE RECHARGER BELT WORKED FOR THE PATIENT IN THE BEGINNING, BUT THEY DON'T USE IT ANYMORE. THE PATIENT HAS TRIED MOVING THEIR BODY IN DIFFERENT POSITIONS, (STANDING, SITTING, LYING DOWN, LEANING FORWARD), BUT THEY STILL STRUGGLE TO MAINTAIN GOOD COUPLING. THE PATIENT STATED THAT LEANING FORWARD SEEMS TO WORK THE BEST FOR THEM, BUT THEY CANNOT REMAIN IN THAT POSITION FOR OVER AN HOUR AND THEIR HAND WILL FALL ASLEEP. THE PATIENT MENTIONED THAT THE INS BATTERY WAS DEAD AT THE TIME OF THE CALL. DURING THE CALL THE RECHARGER APP INDICATED THAT THE INS WAS 10% CHARGED AND THERAPY WAS TURNED OFF. THE PATIENT WAS ABLE TO MAINTAIN A GOOD CONNECTION WHILE STANDING AND LEANING FORWARD, AND THE CONNECTION WAS MAINTAINED FOR A FEW MORE MINUTES WHILE SEATED AND LEANING FORWARD. HOWEVER, THE RECHARGER WOULD LOSE THE CONNECTION AFTER A MINUTE OR TWO AND THE PATIENT HAD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23391503 ↗
• MalfunctionOct 15, 2025Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THEY WENT OUT OF THE COUNTRY AND TOOK THEIR EQUIPMENT WITH THEM AND IT WORKS FINE OVER THERE, BUT DURING THE CALL THE PATIENT WAS ABLE TO CONNECT TO THEIR IMPLANT AND SAW THE LOST DATA MESSAGE. . 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 23300362 ↗
• MalfunctionSep 12, 2025Failure to Interrogate; Migration or Expulsion of Device; Charging Problem; Communication or Transmission Problem; Positioning Problem; Failure to Interrogate; Migration or Expulsion of Device; Charging Problem; Communication or Transmission Problem; Positioning Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). THEY REPORTED THAT THE CAUSE OF THE OX785DA07D ERROR MESSAGE WAS DETERMINED. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED. THE CAUSE OF NOT BEING ABLE TO CONNECT TO THE INS TO TURN THE THERAPY OFF OR TO MAKE A THERAPY ADJUSTMENT WAS NOT DETERMINED. PATIENT STATED THEY COULD NOT CHARGE THEIR DEVICE BECAUSE THAT PARTICULAR DAY . PATIENT SAID TO RESOLVE THE ISSUE THEY JUST KEPT TRYING AND THOUGHT IT TOOK LONGER BECAUSE IT WAS SO DEAD. IT WAS REPORTED THAT THE CAUSE OF THE DIFFICULTY RECHARGING WAS DETERMINED TO BE THE POSITIONING. PATIENT STATED TO NEVER MOVE WHILE RECHARGING. PATIENT STATED THEY RECHARGE EVERY 3 WEEKS AS IT IS EASIER. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED. THE PATIENT STATED THE APPROXIMATE IMPLANT LOCATION WAS NEAR THE TOP OF THEIR RIGHT BUTTOCK. PATIENT STATED ALL WAS CHARGING WELL AND THEY WILL SEE THEIR HEALTH CARE PROVIDER (HCP) ON (B)(6) 2025. PATIENT STATED THE CAUSE OF BEING UNABLE TO FEEL THE EDGES OF THE INS AND THINKING THE INS MIGHT HAVE SLIPPED WAS DETERMINED. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED.

  Patient problems: Distress; Incontinence

  MAUDE report 23042681 ↗
• MalfunctionSep 9, 2025Electromagnetic Interference; Failure to Deliver Energy; Battery Problem; Electromagnetic Compatibility Problem; Electromagnetic Interference; Failure to Deliver Energy; Battery Problem; Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DISFUNCTION AND FECAL INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD SEEN POR ON THEIR HANDSET THAT NOTED THE STIM HAD TURNED OFF. PATIENT TOLD CALLER THIS HAS HAPPENED TWICE, ONCE RECENTLY AND ONCE A COUPLE MONTHS AGO. REVIEWED REASONS FOR POR MESSAGE.

  Patient problems: Insufficient Information

  MAUDE report 23005199 ↗
• MalfunctionAug 6, 2025Electrostatic Discharge; Insufficient Device Problem Information; Electrostatic Discharge; Insufficient Device Problem Information

  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 WHEN IT WAS STORMING AND IF THEY WERE OUTSIDE, IT TWITCHED. THEY HAD JUST BEEN GOING INSIDE SO IT DIDN'T INTERFERE WITH IT BUT IT WAS HARD WHEN THEY ARE OUT AND ABOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728304 ↗
• MalfunctionAug 6, 2025Charging Problem; Charging 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 EVERY TIME THEY CHARGED, IT CUT OFF IN THE MIDDLE BUT THEN THEY WAITED A COUPLE OF MINUTES AND IT STARTED CHARGING AGAIN. IT WAS ABOUT 45% IMPROVEMENT. THEY DID INCREASE IT AND HAD IT SET AT 1.5. THERE WAS NO RASH AT THE MOMENT. A COUPLE OF DAYS AGO THERE WAS, BUT IT HEALED UP ON ITS OWN.

  Patient problems: Rash

  MAUDE report 22728194 ↗
• MalfunctionJul 24, 2025Failure to Interrogate; Battery Problem; Communication or Transmission Problem; Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THEY HAD BEEN GETTING A POR (POWER ON RESET) MESSAGE ON THEIR HANDSET SINCE SATURDAY. PATIENT SAID THEY CHARGED THEIR EXTERNAL DEVICES ALL DAY, BUT THEY WERE STILL NOT ABLE TO CONNECT TO THEIR IMPLANT. AGENT WALKED PATIENT THROUGH TRYING TO CONNECT WITH THEIR IMPLANT, BUT PATIENT KEPT GETTING DEVICE NOT RESPONDING. PATIENT MENTIONED THAT THEY CAN FEEL THE INTERNAL BATTERY BECAUSE THEY ARE VERY THIN. PATIENT WAS NOT TOLD ABOUT THE RECHARGER DEVICE AT ALL SO THE INFORMATION WAS REVIEWED. PATIENT WILL FULLY CHARGE ALL THREE DEVICES AND CALL BACK. PATIENT SERVICES SENT EDUCATIONAL MATERIALS VIA EMAIL.

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

  MAUDE report 22587374 ↗
• MalfunctionJul 15, 2025Use of Device Problem; Malposition of Device; Charging Problem; Insufficient Device Problem Information; Use of Device Problem; Malposition of Device; Charging Problem; Insufficient Device Problem Information

  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 SEEING A 1707 SERVICE CODE WHEN TRYING TO CHARGE THE IMPLANT. THE FOLLOWING TROUBLESHOOTING STEPS WERE PERFORMED: LOCATED THE IMPLANTED NEUROSTIMULATOR BY LOOKING FOR INCISION AND/OR PALPATING THE IMPLANT, . ADDITIONAL TROUBLESHOOTING INFORMATION: PATIENT SAID THEY CAN'T FEEL THE STIMULATOR THROUGH THE SKIN. PATIENT SAID THEY HAVE ADIPOSE TISSUE BACK THERE. PATIENT MENTIONED THEY HAVE A "BIG BUTT" PATIENT CONFIRMED THEY HAVE NOT HAD ANY RECENT WEIGHT GAIN OR WEIGHT LOSS. REPOSITIONED THE WR. PATIENT SAID THEY HAVE NEVER BEEN ABLE TO FEEL THE INS. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT STATED THEY HAVEN'T SEEN THE HEALTHCARE PROVIDER SI NCE JANUARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Urinary Incontinence

  MAUDE report 22506685 ↗
• MalfunctionJun 27, 2025Electromagnetic Interference; Failure to Deliver Energy; Battery Problem; Electromagnetic Interference; Failure to Deliver Energy; Battery 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 YESTERDAY THEY NOTICED THEIR URGENCY SYMPTOMS CAME BACK. THE PATIENT STATED THEY THAT THEY WERE URINATING EVERY 4 MINUTES AND THEY KNEW THEY DIDN'T HAVE A UTI BECAUSE THEY WERE ON MEDICATION FOR THAT SO THEY KNEW IT WASN'T FROM THE UTI. PATIENT STATED UPON THEIR SYMPTOMS RETURNING, THEY WENT TO CHECK THEIR THERAPY SETTINGS TO INCREASE THEIR STIMULATION BUT THEY RECEIVED A MESSAGE ON THEIR HANDSET THAT SAID, "DATA HAS BEEN LOST, CONTACT YOUR CLINICIAN." PATIENT STATED THEY WERE CURRENTLY IN (B)(6) AT THEIR HOTEL BUT THAT THEY SUSPECTED SOMETHING GOT "SCRAMBLED WITH THE IMPLANTED SYSTEM" AFTER GOING THROUGH A SECURITY CHECK POINT AT THE AIRPORT EITHER IN (B)(6) OR IN (B)(6) BUT THEY WEREN'T SURE. PATIENT STATED THEY DID EVERYTHING THEY THOUGHT WAS RIGHT WHEN THEY WENT THROUGH, BUT SOMETHING MIGHT HAVE HAPPENED. PATIENT STATED THEY DIDN'T DO A PAT DOWN AND HAD THE PATIENT WALK THROUGH A SPECIAL MACHINE THAT WAS USED FOR THEM IN (B)(6) AND THEY WERE WORRIED SOMETHING HAPPENED THEN BUT AGAIN THEY WEREN'T SURE BECAUS

  Patient problems: Distress; Incontinence; Insufficient Information; Micturition Urgency; Urinary Frequency / Polyuria

  MAUDE report 22343302 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-OBSTRUCTIVE URINARY RETENTION. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLEEDING IN POCKET SITE DURING PROCEDURE PRIOR TO CLOSING. THERE WERE EXTRA SUTURES AND CAUTERIZATION NECESSARY TO STOP THE BLEEDING. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22238277 ↗

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