INTERSTIM® 3023 (UDI 00613994756558)Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00613994756558), received between Aug 30, 2016 and Sep 30, 2026 — classified as 1 death, 78 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (29 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 147 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945944 ↗
• MalfunctionMay 8, 2026Migration or Expulsion of Device; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THEY THINK THE OLD IMPLANT IS STILL IN THEM AND IT HAS BEEN BOTHERING THEM FOR A LONG TIME, AND SOMETIMES WHEN THEY LAY DOWN IT ROLLS AROUND AND IT IS ALMOST LIKE BEING HIT WITH A ROCK OR SOMETHING. THE CALLER STATES THEY DO NOT KNOW WHERE THEIR EQUIPMENT IS TO CHECK THE DEVICE. THE CALLER DOES NOT KNOW WHAT WAS LEFT IN. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PATIENT DOES NOT HAVE A CURRENT UROLOGIST,

  Patient problems: Discomfort

  MAUDE report 25125652 ↗
• InjuryDec 17, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP). THE HCP REPORTED THAT IT WAS UNKNOWN IF THE CAUSE OF THE WIRES BEING WORN OUT WAS DETERMINED. THE HCP NOTED THE LEAD WAS IMPLANTED IN (B)(6) 2012.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831871 ↗
• InjuryDec 8, 2025Break; Break

  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 HAD A NEW INTERSTIM SYSTEM IMPLANTED ON 2025-NOV-03 WHICH DID NOT APPEAR TO BE REGISTERED AT THE TIME OF THE CALL. THE PATIENT REPORTED THAT THEIR IMPLANTER HAD TOLD THEM THAT "SOME STUFF SHATTERED" DURING THE INS REPLACEMENT SURGERY AND THEY THOUGHT IT WAS SOME KIND OF PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743513 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT PER THE OPERATIVE NOTE; THE PATIENT'S URINARY STIMULATOR WAS INEFFECTIVE AND REMOVED ON (B)(6) 2023. THE POCKET SITE HAD EVIDENCE OF CHRONIC INFLAMMATION AND A MODERATE SEROUS AMOUNT OF FLUID WAS NOTED UPON ENTRY INTO THE CAPSULE AND WAS SENT FOR CULTURE.

  Patient problems: Fluid Discharge; Inflammation

  MAUDE report 22877242 ↗
• InjuryMay 28, 2025Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE HOSPITALIZATION WAS RELATED TO THE DEVICE. THE DEVICE NO LONGER WORKS AND HAD FAILED THEM. THE CAUSE OF THE INABILITY TO CONNECT WAS DUE TO IT BEING TOO OLD. THEY WANT AN UPDATED BATTERY, ONE THAT WOULD RECHARGE ITSELF. THE ISSUE WAS NOT YET RESOLVED.

  Patient problems: Constipation

  MAUDE report 22101082 ↗
• InjuryMay 20, 2025Migration or Expulsion of Device; Unintended Collision; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Unintended Collision; Adverse 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 THEY'D FALLEN BEFORE WITH THEIR PREVIOUS IMPLANT AND "DISLODGED THE WIRES" SO THEY HAD TO GO BACK IN FIX IT AND THE PATIENT STATED THEY WONDERED IF THAT WAS WHAT WAS GOING ON NOW BUT NOTED AGAIN, THEY'D REACH OUT TO THEIR HCP. PATIENT MENTIONED THEY HAD SEEN THE MALE REP AT THEIR HCP OFFICE A FEW TIMES RELATED: (B)(6), FELL/MAX SETTING/ SUDDEN ROS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053568 ↗
• MalfunctionApr 28, 2025Electromagnetic Interference; Insufficient Device Problem Information; Electromagnetic Interference; Insufficient Device Problem Information

  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'VE HAD TO GO TO A "REGULAR WALK THROUGH" AT THE AIRPORT FOR SECURITY AND FELT LIKE THEIR INS GOT "MESSED UP" FROM IT. PATIENT LISTED EVENT DATE AS 2 YEARS AGO. PATIENT MENTIONED THEY WEREN'T WORRIED AT THE TIME BECAUSE THEY WERE ALREADY HAVING ISSUES WITH THEIR INS . AGENT SUGGESTED PATIENT FOLLOW-UP WITH MANAGING HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918357 ↗
• InjuryApr 23, 2025Energy Output Problem; Impedance Problem; Insufficient Device Problem Information; Energy Output Problem; Impedance Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT, PER CALL WITH HCP FROM PATIENT'S PRIMARY CARE PHYSICIAN'S OFFICE ON (B)(6) 2025, CALLER VERIFIED THAT PT HAD A BATTERY CHANGE ON (B)(6) 2025 BECAUSE THE OLD DEVICE WAS NO LONGER FUNCTIONING. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP CLARIFIED THE STATEMENT "THE OLD DEVICE WAS NO LONGER FUNCTIONING" BY NOTING "IMPEDANCES ALL AMBER - COULD NOT PROGRAM - POOR SYMPTOM CONTROL." THE HCP NOTED THIS ISSUE WAS NOT CAUSED BY NORMAL BATTERY DEPLETION AND THE CAUSE ITSELF WAS NOT DETERMINED. THE HCP NOTED THAT THE LIKELY CAUSE OF THE ISSUE WAS "BAD LEAD MOST LIKELY, SINCE IPG WAS A BRAND NEW [INTERSTIM] X." WHEN ASKED WHAT STEPS WERE/WILL BE TAKEN TO RESOLVE THE ISSUE, THE HCP INDICATED "REPLACING OLD LEAD - NOT SCHEDULED YET." HCP NOTED THAT THE OLD BATTERY WAS DISCARDED BUT THE LEAD WILL BE RETURNED AFTER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894507 ↗
• MalfunctionOct 17, 2024Unintended Collision; Insufficient Device Problem Information; Unintended Collision; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT ASKED IF BATTERIES COULD, "JUST STOP WORKING." PATIENT REPORTED THEY THOUGHT THEIR BATTERY STOPPED WORKING BECAUSE OF SYMPTOMS THEY'VE BEEN EXPERIENCING SINCE ABOUT MARCH. PATIENT REPORTED SYMPTOMS OF BURNING, SHARP, STABBING PAIN AT THE LOWER VAGINAL AREA ALONG WITH FREQUENCY AT NIGHT. PATIENT MENTIONED THEY'VE BEEN CHECKED FOR BLADDER INFECTIONS FOR THE LASTFEW MONTHS. AGENT ASKED PATIENT IF THEY EVER TRIED TURNING THEIR THERAPY OFF TO SEE IF IT WOULD AFFECT THE PAIN AT ALL AND PATIENT SAID NOT SINCE THEY DEVELOPED THE SYMPTOMS. PATIENT VERBALIZED THEY WERE SCARED TO TURN THERAPY OFF FOR FEAR THAT IT WOULD MAKE THINGS WORSE. PATIENT SAID THEY HAD A COUPLE SEIZURES WHERE THEY PASSED OUT AND FELL ON THE FLOOR, AND WONDERED IF THAT COULD HAVE CAUSED DAMAGE. AGENT REVIEWED IT WAS POSSIBLE, BUT REASSURING THAT CONNECTION COULD BE ESTABLISHED AND STIMULATION FELT. PATIENT WAS UNSURE IF IMPEDANCE CHECK WAS DONE AT LAST APPOINTMENT. PATIENT REPORTED THEY WENT TO MANAGING HEALTHCARE PROVIDER'S (HCP) OFFICE LAST WEEK WHO WAS ABLE TO CONNECT TO INS, ADJUST SE

  Patient problems: Pain; Urinary Frequency / Polyuria

  MAUDE report 20470201 ↗
• MalfunctionAug 21, 2024Communication or Transmission Problem; Electromagnetic Compatibility Problem; Communication or Transmission 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 PATIENT STATES THEY HAD BACK SURGERY ON THE 1ST AND THEY TURNED OFF THEIR STIMULATOR AND NOW THEY CAN'T GET IT BACK ON WITH THEIR PROGRAMMER. AGENT HAD PATIENT ATTEMPT TO CONNECT WITH THEIR NEUROSTIMULATOR WITH AND WITHOUT THE ANTENNA ON, HOWEVER THE PATIENT CONTINUALLY ENCOUNTERED THE POOR COMMUNICATION SCREEN. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. PATIENT CALLED BACK FOR ASSISTANCE ON TURNING ON THERAPY WITH 3037 PROGRAMMER AND ANTENNA. PATIENT WAS ABLE TO CONNECT , THERAPY WAS ON. PATIENT STATES SINCE BACK SURGERY GOING TO THE BATHROOM EVERY HOUR. PATIENT INCREASED SETTINGS ON THE CALL AND STATES BEING ABLE TO FEEL IT NOW. PSS REVIEWED THERAPY CONSIDERATIONS. AGENT REQUESTED THAT PATIENT CONTACT THEIR HCP TO RECEIVE DEVICE INFORMATION AND CALL MDT BACK FOR FURTHER TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THEIR CONNECTION ISSUES.

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 20019693 ↗
• MalfunctionFeb 23, 2024Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  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 CONTROLLER GOES THROUGH BATTERIES VERY QUICKLY AND THAT HAS ALWAYS BEEN THE CASE. PATIENT ALSO REPORTS HAVING A RETURN OF SYMPTOMS THAT SEEMED TO HAVE COINCIDED WITH A LACK OF STIM PERCEPTION THAT STARTED IN OCT OR NOV OF LAST YEAR. THE PT STARTED AS OFF 'MINOR AT FIRST' AND THE PT STATES THERE WAS NOTHING THAT PROMPTED THIS CHANGE, NO FALLS/TRAUMA/ETC...THE CALLER STATES TYPICALLY HE ONLY RAN STIM AT 2.5V AND HAD NOT CHANGED FROM PROGRAM 4, PT DID NOT KNOW HOW TO SWITCH PROGRAMS. THE CALLER WAS IN THE 8440 SESSION WHEN THEY CALLED IN AND RAN ELECTRODE IMPEDANCES AT THE NORMAL DEFAULT SETTINGS AND NOTED ONE CONTACT PAIR WAS >4K OHMS 3/0 BUT NOTED NOTHING ELSE OUT OF RANGE OR LOWER THAN 300 OHMS. THE CALLER SAID BATTERY LONGEVITY SHOWED 120 MONTHS AND BATTERY WAS 'OK'. THE CALLER HAD NOT DONE ICON SYNCH PROCESS WHEN FIRST INTERROGATING PT WITH 8840 SO NO PROGRAMMING ADJUSTMENTS COULD BE MADE AT THAT TIME TO THE SPECIFIC GROUPS. CALLER EXITED THE 8840 SESSION AND THEN STARTED

  Patient problems: Insufficient Information

  MAUDE report 18768841 ↗
• MalfunctionDec 27, 2023Failure to Deliver Energy; Unintended Collision; Communication or Transmission Problem; Failure to Deliver Energy; Unintended Collision; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. THE HCP REPORTED THAT THEY HAD DIFFICULTIES WITH CONNECTING TO THE PATIENTS DEVICE FROM CLINICIAN APP. AGENT ASSISTED WITH TROUBLESHOOTING AND CALLER ABLE TO SUCCESSFULLY CONNECT TO PATIENTS INS. CALLER MENTIONED THE PATIENT HAD HAD SEVERAL FALLS LATELY. MOST RECENTLY, THEIR WHEELCHAIR FELL ON TOP OF THEM, WHICH WAS 2.5 WEEKS AGO. CALLER REPORTED PATIENT WAS UNABLE TO FEEL STIM, BUT THAT THEY TYPICALLY DID NOT OFTEN FEEL THE DEVICE ACTIVELY STIMMING. CALLER STATED THAT THE PATIENT WAS LAST ABLE TO CONNECT TO THEIR INS A MONTH AGO. CALLER STATED THE PATIENT RECENTLY HAD DIFFICULTY CONNECTING TO DEVICE, BUT SUSPECTED IT WAS BECAUSE THEY WERE NOT USING INTERSTIM X MYTHERAPY APP (RESOLUTION TO CALLER'S INITIAL CONCERN WAS USING CLINIC INTERSTIM X APP). CALLER CONDUCTED AN IMPEDANCE TEST WHILE AGENT WAS ON THE PHONE. THE IMPEDANCE CHECK WAS SUCCESSFUL. THERE WERE NO IMPEDANCE PROBLEMS OR ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406971 ↗
• MalfunctionNov 16, 2023Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Noise, Audible; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Noise, Audible

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER AND PATIENT REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIM ULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PROGRAMMER SHOWED EOS BUT THE PRIOR STIMULATOR LASTED 10 YEARS, THEIR CURRENT INS IS JUST OVER 5 YEARS OLD. IT WAS REVIEWED OVER TIME IF HIGHER STIMULATION LEVELS ARE NEEDED FOR PATIENT'S THERAPY, INS BATTERIES CAN DEPLETE QUICKER AND CALLER CONFIRMED UNDERSTANDING THAT MAY BE THE NORMAL BATTERY DEPLETION BECAUSE PATIENT HAD BEEN USING LOWER SETTINGS, IN THE 4S AND 5S AND THEY HAVE BEEN IN THE 7S. WORKED WITH CALLER TO SYNCH WITH THE INS AND WHEN THEY DID PATIENT EXPRESSED A NOISE STATING IT GAVE THEM A SHOCK, THEY FELT A STRONG SIGNAL GOING TO THEIR BUTT. LATER PT CONFIRMED THAT WENT AWAY. CALLER REPORTED SEEING EOS. REVIEWED THE PROGRAMMER IS READING THE INS WE DO NOT EXPECT IT IS PROVIDING ANY STIMULATION. PATIENT SAID THE PATIENT HAS NOT HAD ANY MEDICAL TESTS OR PROCEDURES NOR HAD ANY MAJOR FALLS, THEY MAY HAVE FALLEN A LITTLE BIT IN THE BEDROOM. CALLER SAID PATIENT HAS NOT HAD A RETURN OF SYMPTOMS, THEY SEEM TO BE URINATING. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. T

  Patient problems: Electric Shock

  MAUDE report 18148622 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT PER ACTIVITY RESPONSE FROM MANUFACTURER REPRESENTATIVE (REP) ON 2023-NOV-08 "PER PHYSICIAN PATIENT HAVING ALL IMPLANTS REMOVED DUE TO METAL TOXICITY ALLERGY. ALL IMPLANTS EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18130134 ↗
• MalfunctionMay 30, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT STATED THEY NEED TO HAVE A BRAIN MRI AND NEEDED TO KNOW HOW TO CONNECT TO THE INS. THEIR DEVICE HAD BEEN OFF BECAUSE IT WAS A SHOCKING IN THEIR LEGS. IF THE STIMULATION WAS TOO HIGH, IT'S ALWAYS SHOCKED THEM, BUT THEN IT STARTED TO JUST STAY IN A STEADY PAIN IN THEIR LEGS. IF THEY TURNED STIM OFF, THE PAIN WOULD GO AWAY. THEY WERE ALSO INTERESTED IN TURNING IT BACK ON TO SEE IF IT'S STILL WORKING . THE PATIENT WAS ABLE TO CONFIRM STIM IS OFF AND INS IS STILL FUNCTIONING. THEY HAVE A FOLLOW UP APPOINTMENT ON (B)(6). WITH THEM AND PLANS TO DISCUSS USING THE THERAPY AGAIN WITH THEM.

  Patient problems: Electric Shock; Pain

  MAUDE report 17019831 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; 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. IT WAS REPORTED THAT THEY HAD UTI'S AND THOUGHT IT WAS MAYBE THE DEVICE ACTING UP AND WANTED TO CHECK THE INS BATTERY STATUS. THEY HAD BEEN EXPERIENCING HORRIBLE PAIN THAT STARTED MAYBE 2 MONTHS AGO BUT HAVE SINCE GOTTEN ON SOME MEDS AND IS MUCH BETTER. PATIENT HAS NOT HAD ANY FALLS OR TRAUMAS THAT WOULD MAKE THEM THINK THERE IS AN ISSUE WITH THE DEVICE. AGENT REVIEWED HOW TO CHECK FOR LOW INS BATTERY ICON AND CONFIRMED THE INS BATTERY HAS NOT REACHED A LOW STATE AND PATIENT WAS ABLE TO SYNC WITH THE INS NORMALLY.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 17017707 ↗
• InjuryNov 17, 2022Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information; Inappropriate/Inadequate Shock/Stimulation; 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 THE IMPLANT  WAS SHORTING OUT AND CAUSING PAINS, PAIN ON THE SIDE, SINCE IT WAS IMPLANTED ON THE RIGHT SIDE OF THE BODY. KEPT ON ZAPPING, RESULTING TO SCAR THAT NEEDS TO BE TREATED UNTIL NOW SINCE IT WONT GO AWAY. THE IMPLANTED  DEVICE WAS EXPLANTED 1 WEEK AFTER IT WAS IMPLANTED.

  Patient problems: Electric Shock; Pain; Scar Tissue

  MAUDE report 15819389 ↗
• InjuryMar 31, 2022High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM, GASTROINTESTINAL/ PELVIC FLOOR, URINARY/BOWEL DYSFUNCTION, AND URGE INCONTINENCE. IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCES AND A LEAD REPLACEMENT WAS PERFORMED. THE CALLER INDICATED ALL THE COMBINATIONS WERE IN THE ORANGE. PATIENT DID WANT FULL BODY ELIGIBLE LEAD, SO CALLER INDICATED IT WAS OKAY TO REPLACE THE LEAD. THE 3093 LEAD LISTS IMPLANT DATE OF 2002, BUT THE 3093 LEAD WAS NOT AVAILABLE AT THAT TIME. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967494 ↗
• MalfunctionFeb 16, 2022Migration or Expulsion of Device; Unintended Collision; Energy Output Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Unintended Collision; Energy Output Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A FRIEND/FAMILY MEMBER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR INTERSTIM - OTHER. IT WAS REPORTED THAT THE REASON FOR THE CALL WAS THAT THE CALLER WANTED TO KNOW IF THE PATIENT PROGRAMMER NEEDED TO BE SENT BACK TO THE MANUFACTURER. INFORMATION WAS REVIEWED, IN THAT THE PATIENT PROGRAMMER DID NOT NEED TO BE SENT BACK. THE CALLER SAID THE PATIENT PASSED AWAY (NO ALLEGATION RELATED TO DEVICE/THERAPY). THEY SAID THE DEVICE STOPPED WORKING ABOUT TWO MONTHS BEFORE THE PATIENT PASSED AWAY. THE CALLER SAID THE PATIENT HAD A FALL, AND THOUGHT WHEN THEY FELL THEY "PULLED THE WIRE," WHICH WAS WHY THE DEVICE STOPPED WORKING.

  Patient problems: Insufficient Information

  MAUDE report 13544387 ↗
• InjuryJan 26, 2022Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  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  THEIR INS WAS LOOSE AND BOTHERING THEM. IT KEEPS MOVING, WIGGLES AND TURNS AND WAS UNCOMFORTABLE. THEIR HEALTHCARE PROFESSIONAL (HCP) INDICATED IT WASN'T IN A GOOD SPOT BECAUSE IT WAS STICKING OUT. PATIENT STATED THAT HCP MOVED INS FROM BACK TO BUTTOCK AND THEY BELIEVED THIS WAS PERFORMED AT THE (B)(6) 2021 PROCEDURE.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 13358887 ↗
• MalfunctionDec 10, 2021Intermittent Continuity; Failure to Deliver Energy; Insufficient Device Problem Information; Intermittent Continuity; Failure to Deliver Energy; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT WAS GOING TO PHYSICAL THERAPY AND THEY WANTED TO SHUT OFF THE STIMULATION. IN TALKING, THE PATIENT MENTIONED THE LEADS WEREN'T WORKING CORRECTLY AND THE SYSTEM IS OLD. THE DOCTOR LOOKED AT THE SYSTEM A WEEK AGO FOR PROGRAMMING, AND IT SHUT OFF ON IT'S OWN. THE DOCTOR CHECKED THE SYSTEM TWO YEARS AGO AND THEY ONLY HAD A COUPLE ELECTRODES THEY COULD USE. THE PATIENT SAID, THEY HAVEN'T FELT THE SYSTEM WORK PROPERLY IN OVER TWO YEARS. DOCUMENTED REPORTED EVENT. NO FURTHER ACTION WAS TAKEN BY PATIENT SERVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977841 ↗
• InjuryNov 18, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT IT WAS UNKNOWN WHEN THE PATIENT'S ADDITIONAL SURGERY WAS SCHEDULED FOR. IT AS NOT A SURGERY WITH THE INITIAL IMPLANTER, BUT WITH ANOTHER PHYSICIAN. THE PHYSICIAN THAT THE REP WORKED WITH DID NOT HAVE THE INFORMATION. IF WAS UNKNOWN IF THE ISSUE WAS RESOLVED, BECAUSE IT WAS UNCLEAR IF THE PATIENT HAD THEIR SURGERY YET OR NOT. THE REP ASSUMED THAT THEY HAD HAD THE SURGERY AT THIS POINT, BUT WERE UNCERTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12838927 ↗
• MalfunctionNov 3, 2021Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED ¿USED 1.7V 210 AND 14HZ =EOS 4.6 YEAR.¿ THE CALLER ASSUMED THERE HAD BEEN A POWER ON RESET (POR ,) AS THE 8840 WAS SHOWING >120 MONTHS BUT THEY DIDN¿T HAVE ANY INFORMATION AS THEY¿D RECEIVED A MESSAGE. THE CALLER SAID THEY¿D COMPLETE AN MPXR ONCE THEY CALLED THE CLINIC. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) ON 2021-OCT-13. IN RESPONSE TO THE INQUIRY FOR CLARIFICATION OF THE STATEMENT: ¿USED 1.7V 210 AND 14HZ =EOS 4.6 YEAR,¿ AND IF THEY WERE THE CURRENT DEVICE SETTINGS WHEN THE DEVICE WAS STATED TO BE AT EOS AFTER 4.6 YEARS OR IF THEY WERE THE LONGEVITY CALCULATION SHOWING THE YEARS REMAINING UNTIL EOS (AND THE PATIENT¿S CURRENT SETTINGS,) THE REP SIMPLY REPLIED ¿YES.¿ IN RESPONSE TO THE INQUIRY FOR IF THERE HAD BEEN A POWER ON RESET (POR) THE REP REPLIED ¿UNKNOWN, BUT ASSUMED.¿ IN RESPONSE TO THE INQUIRY FOR IF A CAUSE HAD BEEN DETERMINED FOR THE POR AND WHAT MOST LIKELY CAUSED OR CONTRIBUTED TO THE ISSUE THE REP SAID ¿UNKNOWN.¿ IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749617 ↗
• InjurySep 27, 2021Failure to Deliver Energy; Impedance Problem; Insufficient Device Problem Information; Failure to Deliver Energy; Impedance Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE DEVICE BEING 'BROKEN' WAS NOT CAUSED BY NORMAL BATTERY DEPLETION. THE CAUSE WAS UNKNOWN; "IT SIMPLY STOPPED WORKING AND SHOWED IMPEDANCES BUT DON'T KNOW WHY." THE DEVICE WAS REPLACED ON (B)(6) 2021 AND THE ISSUE WAS RESOLVED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Insufficient Information; Pain

  MAUDE report 12533740 ↗

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