INTERSTIM® 3058 (UDI 00613994287724)Recalls & reported problems

Summary

The FDA's MAUDE database contains 817 adverse event reports that list this exact device (DI 00613994287724), received between May 20, 2009 and Sep 30, 2026 — classified as 452 injuries, 365 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (211 reports).

5 other recalls cover devices cleared under the same FDA submission (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 817 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Premature Discharge of Battery; Insufficient Device Problem Information

  Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (INS) for u urinary dysfunction/sacral nerve stim It was reported that the device is no longer working and probably only lasted 1.5 to 2 years. .The patient was redirected to their healthcare provider to further address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947774 ↗
• InjuryJul 30, 2026Insufficient 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 device didn't work after implant and was removed about 3 months after the patient (pt) received the implant. The agent notified patient registration of device status.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50087279 ↗
• InjuryJul 29, 2026Insufficient 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 went in 5-10 years ago and they put in a second stimulator because the first one broke.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075659 ↗
• InjuryMay 21, 2026Entrapment of Device; Migration or Expulsion of Device; Difficult to Remove; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PELVIC PAIN/OTHER AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE DEVICE SERVED ITS PURPOSE AND THEY HAD IT REMOVED 10 YEARS LATER BECAUSE IT WAS A LARGE PIECE AND THE WIRES GREW INTO THEIR TISSUE SO WHEN IT WAS REMOVED SOME OF THE WIRES WERE LEFT BEHIND AND THEY CAN FEEL THEM. THE PATIENT SAID, NOW THEY NEEDED TO TAKE A VERY HIGH POWERED MRI AND THE DOCTORS/ RADIOLOGISTS WERE CONCERNED. THE PATIENT SAID THEY HAVE HAD MRIS BEFORE AND NOTHING HAD HAPPENED TO THEM BUT THIS HIGH POWERED ONE MAY HAVE AN EFFECT ON WHAT WAS LEFT INSIDE THEM. THE AGENT REVIEWED MRI INFORMATION AND REDIRECTED TO THEIR DOCTOR, PROVIDED TECH SUPPORT PHONE NUMBER FOR HEALTHCARE PROVIDERS (HCP) TO CALL.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245503 ↗
• InjuryMar 31, 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. IT WAS REPORTED THAT THE STIMULATOR HAD NOT WORKED IN A LONG TIME. THE CALLER WAS NOT WITH THE PATIENT AT THE TIME OF THE CALL FOR FURTHER CLARIFICATION. REGARDING EVENT DATE, HCP REPORTED THAT PATIENT SAID THE INS STOPPED WORKING IN 2012. THE CALLER REPORTED THAT THE PATIENT INDICATED THE DEVICE HAD NOT WORKED SINCE "2012". THE AGENT REVIEWED DEVICE REGISTRATION. THE CALLER HAD NO FURTHER DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746053 ↗
• MalfunctionMar 17, 2026Premature Discharge of Battery; Battery Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE DOCTOR PUT THE 2ND DEVICE IN ON THE LEFT NERVE AS SIGNALS GOING TO THE BRAIN FROM THE DAMAGED LEFT NERVE COULD BE CONTROLLED BY SIGNALS FROM THE LEFT INTERSTIM DEVICE POSSIBLY BY BRUTE FORCE. THE PATIENT HAD 2 OPTIONS ON THEIR DEVICE. REGULAR UP AND DOWN CONTROLS AND A CHANGE OF PROGRAM OVER TO A LOOPING FUNCTION WITH MADE ALL OF THE LEAD CONTACTS POSITIVE AND THE CASE WITH BATTERY NEGATIVE GOING THROUGH THE WHOLE BODY FROM THE DEVICE IN THE LEFT BUTTOCK ALL THE WAY TO S3 LEFT SIDE FELT ALL THE WAY TO THE GROIN. THE PATIENT ENDED UP WITH GETTING FLAGGED FOR LOW BATTERY AFTER 10 MONTHS. THE MANUFACTURER TURNED THE SAFETY OFF AND LET IT RUN UNTIL DEPLETED. AT 13 MONTHS IT WAS TOTALLY DEPLETED WITH THE MANUFACTURER NOT GETTING ANY RESPONSE AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620751 ↗
• InjuryMar 16, 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. THE PATIENT STATED THAT THEY HAD TRIED 2 DEVICES. THE CAUSE OF THE THERAPY NOT WORKING WAS NOT DETERMINED. THEY REPORTED THAT THEY HAD NO IDEA WHAT MOST LIKELY CAUSED OR CONTRIBUTED TO THIS ISSUE. THEY REPORTED THAT STEPS TAKEN TO RESOLVE THE ISSUE INCLUDED THAT THEY TRIED A SECOND DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24608060 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT MENTIONED THAT THE URINARY STIM INS AND THE URINARY STIM LEAD WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24378867 ↗
• InjuryFeb 9, 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. IT WAS REPORTED THAT THE CALLER STATED THAT THE SYSTEM WAS REMOVED ON (B)(6) 2024 DUE TO MALFUNCTIONING. THE AGENT INQUIRED, CALLER'S NOTE INDICATED THE SYSTEM WAS NOT EFFECTIVE AND WAS PAINFUL. THE CALLER DID NOT HAVE EVENT DATE(S) RELATED TO THE NOTED ALLEGATIONS. THE CALLER DID NOT KNOW WHO WAS MANAGING DEVICE. SEE (B)(4) FOR OMITTED INFORMATION ON EXPLANT DIFFICULTIES.

  Patient problems: Pain

  MAUDE report 24298501 ↗
• MalfunctionFeb 9, 2026Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE LEAD SEPARATED WITHIN THE CASING AND SNAPPED AT THE ENTRANCE INTO THE NERVE ROOT WHEN REMOVAL ATTEMPT WAS MADE (SEE 708900169 FOR OMITTED INFORMATION ON THE DEVICE EXPLANT). THE LEAD APPEARED TO HAVE BEEN FRAGMENTED. THE AGENT REVIEWED OPTIONS FOR MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24298422 ↗
• InjuryJan 23, 2026Failure to Interrogate; Unintended Collision; Communication or Transmission 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 HAVE HAD MULTIPLE DEVICES SINCE THEY WERE A KID AND A LOT OF THEM HAVE HAD "WEAR AND TEAR" HE PATIENT TO CLARIFY WHAT THEY MEANT BY "WEAR AND TEAR" THE PATIENT REPORTED THEY WERE A CHILD WHEN THEY FIRST GOT IMPLANTED AND THEY WERE CLUMSY AND WOULD FALL A LOT AND DO NOT KNOW IF IT WAS ENOUGH TO DAMAGE A LEAD OR SOMETHING. THE PATIENT HAS HAD 3 INTERSTIM IMPLANTS, BUT THEY HAVE NEVER HAD AN INS BATTERY DIE. THEY WOULD HAVE TO GET THE BATTERIES REPLACED BECAUSE THEY WOULD LOSE THE ABILITY TO COMMUNICATE WITH IT/PROGRAM IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164618 ↗
• InjuryJan 15, 2026Migration or Expulsion 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 THE PATIENT ALSO MENTIONED THE LEADS HAD MOVED IN THEIR BODY WHEN GIVING BIRTH IN 2008, SO THEY HAD TO REMOVE THE LEAD AND PUT IT ONE ON THE OTHER SIDE OF THEIR  BODY.  THE PATIENT DOES NOT THINK THE LEAD IS STILL IMPLANTED AND THINKS IT WAS REMOVED. SEE RELATED PE  708820970/ NOT WORKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24083000 ↗
• InjuryDec 29, 2025Intermittent Continuity; Patient Device Interaction Problem; Intermittent Continuity; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THEIR FIRST STIMULATOR LASTED QUITE A LONG TIME, 5 OR 6 YEARS. THEY KNEW THEY HAD TO HAVE IT CHANGED BECAUSE THEY GOT A TIGHTNESS IN THEIR GROIN AND PULSATING. IT WAS PAINFUL WHEN THEY WERE LAYING ON THE FLOOR DOING YOGA AND THEY KNEW IT WAS TIME TO REPLACE IT. THE AGENT ASKED THE PATIENT FOR DATES FOR THE DEVICE REPLACEMENT DUE TO TIGHTNESS AND PULSATING, AND THE PATIENT SAID THEY ROUGHLY HAD 6 YEARS BETWEEN CHANGING BATTERIES.

  Patient problems: Insufficient Information; Pain

  MAUDE report 23906707 ↗
• InjuryDec 17, 2025Break; Connection Problem; Break; Connection Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT WITH A PREVIOUS IMPLANT, THE SURGEON WASN'T ABLE TO REMOVE THE LEAD FROM THE PREVIOUS SYSTEM AND SAID THAT THEY BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831753 ↗
• MalfunctionOct 24, 2025Premature Discharge of Battery; Premature Discharge of Battery

  *THIS EVENT IS NO LONGER A REPORTABLE EVENT. THE MDR DECISION WAS UPDATED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE*

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381160 ↗
• InjuryOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  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 THE FIRST TIME THEY HAD A LOT OF DISCOMFORT AND THAT IT WAS "BECAUSE OF WHAT THEY WERE DOING" BEFORE EVEN "WAKING UP" WITH GOING "UP AND DOWN" WITH THE THERAPY. WHEN ASKED FOR CLARIFICATION, PATIENT ANSWERED BY SAYING THAT A SHORT TIME AFTER THE INS WAS IMPLANTED (APPROXIMATELY 4 WEEKS AFTER) THEY THOUGHT THERE WAS A PROBLEM WITH THE SETTINGS AND TRIED TO CHANGE THE SETTINGS THEMSELVES. PATIENT SAID THEY WENT THROUGH "A FEW DAYS OF HELL," AND THAT IT FELT LIKE A "TRUCK BATTERY" WAS ATTACHED TO THEM. THE PATIENT SAID THEY CALLED THE MANAGING HEALTHCARE PROVIDER (HCP) WHO TOLD THEM TO TURN THE STIM DOWN AND COME INTO THE OFFICE. THE PATIENT SAID THEY WERE TOLD AT THAT POINT NOT TO ADJUST THE SETTINGS WITHOUT DOCTOR OVERSIGHT.

  Patient problems: Discomfort; Insufficient Information; Sleep Dysfunction

  MAUDE report 23365249 ↗
• InjurySep 17, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; 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  THE INS HAD TO BE EXPLANTED BECAUSE THEIR BODY WAS REJECTING IT. THE PATIENT THINKS THIS OCCURRED IN (B)(6) 2011. THE PATIENT STATED THAT THE EXPLANT PROCEDURE TOOK A LONG TIME, SO THE HCP DECIDED TO LEAVE A LITTLE PIECE OF THE LEAD IN THE SCAR TISSUE. THE PATIENT MENTIONED THAT THEY HAD FLUOROSCOPY WHICH DETECTED A METALLIC FOREIGN BODY, WHICH WAS THEN IDENTIFIED AS THE LEAD FRAGMENT. THE PATIENT'S REASON FOR CALLING WAS TO FIND OUT IF THEY COULD GET AN MRI OF THE SACRAL AND LUMBAR AREA. THE PATIENT MENTIONED THAT THEY WERE HAVING BACK PAIN AND THEIR HCP WAS TRYING TO DETERMINE THE ROOT CAUSE. . THE AGENT REVIEWED MRI COMPATIBILITY. THE AGENT REVIEWED THAT AN HCP WILL NEED TO FILL OUT AN MRI ELIGIBILITY FORM FOR LEAD FRAGMENTS. THE AGENT EMAILED PHYSICIAN LISTINGS TO THE PATIENT. AGENT ALSO EMAILED PRS TO UPDATE THE DEVICE RECORD.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body Reaction; Insufficient Information; Pain

  MAUDE report 23077230 ↗
• MalfunctionSep 17, 2025Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem; Failure to Interrogate; Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission 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 HAVEN'T HAD THE IMPLANT ON "FOR DECADES" AND THAT THE IMPLANT HAD SHOCKED THEM SO THEY TURNED OFF THE IMPLANT. THE PATIENT ALSO NOTED THAT THE IMPLANT WASN'T WORKING FOR THEM AND THEY HAD MESSED WITH THE IMPLANT SETTINGS FOR A WHILE BUT THEY COULD NEVER GET THE IMPLANT CALIBRATED TO WHERE IT HELPED THEM WITH THEIR SYMPTOMS. THE PATIENT SAID THEY WERE NOT ABLE TO GET EXTERNAL EQUIPMENT TO CONNECT WITH THE IMPLANT. PS REVIEWED IMPLANT BATTERY LONGEVITY INFO AND REDIRECTED PATIENT TO HCP.

  Patient problems: Electric Shock

  MAUDE report 23075415 ↗
• MalfunctionSep 10, 2025Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT DURING REMOVAL, APPROXIMATELY 1 IN OF WIRE BROKE OFF <(>&<)> WAS LEFT IN THEIR BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23018766 ↗
• InjuryAug 7, 2025Migration 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 OTHER AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT STATED THAT THEY HAD THEIR INS REMOVED YESTERDAY. THE PATIENT STATED THAT THE INS WAS "FLAT IN THEIR HIP" AND WAS PLACED IN A BAD SPOT AND NEEDED TO BE PUT UP HIGHER. WHEN ASKED FOR FURTHER CLARIFICATION AND AN EVENT DATE, THE PATIENT DID NOT PROVIDE A CLEAR ANSWER. THE PATIENT CONFIRMED THAT THEIR INS WAS INDICATED FOR BOTH BLADDER AND BOWEL TREATMENT. THE PATIENT WAS VERY DIFFICULT TO UNDERSTAND, AND THE AGENT DID THEIR BEST TO DOCUMENT NECESSARY INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738144 ↗
• InjuryAug 5, 2025Adverse 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 URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THEY NEVER FELT THE THERAPY DID THEM ANY GOOD.

  Patient problems: Insufficient Information

  MAUDE report 22720344 ↗
• InjuryJul 23, 2025Adverse 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 URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. IT WAS REPORTED THAT A PATIENT LETTER WAS RECEIVED INDICATING THAT THEIR LEFT IMPLANT WAS REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22579028 ↗
• InjuryJun 27, 2025Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT, PER AN OPERATIVE NOTE THE CALLER HAD, THE PATIENT'S LEAD WAS CUT THROUGH DURING A PROCEDURE ON (B)(6) 2010 THAT WAS MEANT TO REPOSITION THE INS BECAUSE THE INS HAD MIGRATED THROUGH THE SKIN. THE PATIENT THEN SUBSEQUENTLY HAD THEIR LEAD AND INS REPLACED IN JULY 2010 BUT THE CUT LEAD REMNANT REMAINED. CALLER DOESN'T KNOW THE LENGTH OF THE LEAD FRAGMENT. AGENT SENT MRI GUIDELINES TO CALLER SO THEY HAVE THE DETAILS AROUND LEAD FRAGMENTS. PER CALLER, THE SYSTEM HAS BEEN FULLY REMOVED SO THAT ONLY THE LEAD REMNANT REMAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pocket Erosion

  MAUDE report 22343327 ↗
• InjuryJun 2, 2025Failure to Interrogate; Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. IT WAS REPORTED THAT THE PATIENT STATED THAT THE DEVICE HAS NOT WORKED FOR QUITE A WHILE. PATIENT STATED THEY WERE HAVING BLADDER PROBLEMS AND THEY WENT AWAY BUT NOW THEY ARE HAVING THEM AGAIN. PATIENT ALSO MENTIONED THEY HAVE PROBLEMS WITH OVERACTIVE BLADDER AND THEY GET UP TO GO TO THE BATHROOM UNNECESSARILY TOO MUCH. PATIENT MENTIONED THEY USED TO HAVE TO CATHARIZE AND NOW THEY DON'T HAVE A PROSTATE BUT SOMETIMES IT IS A STRUGGLE TO GO BUT IT IS NOT LIKE IT WAS. PATIENT STATED THE PROGRAMMER DOES NOT CONNECT WITH INS AND INS IS AT EOS. PATIENT THINKS EOS MAY HAVE BEEN ABOUT A YEAR AGO. PATIENT ASKING ABOUT INS BEING REPLACED. AGENT REVIEWED AND REDIRECTED PATIENT TO THEIR HCP. PATIENT ASKED ABOUT MRI COMPATIBILITY, AND AGENT REVIEWED. PATIENT DOES NOT HAVE A MANAGING DOCTOR SO AGENT EMAILED PHYSICIAN LISTINGS. (CON): ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2025-05-09 THEY REPORTED THAT THE CAUSE WAS NOT DUE TO BATTERY DEPLETION AND IT WAS UNKNOWN AND THEY GOT A REPLACEMENT AND NO FURTHER ACTION WILL BE TAKEN

  Patient problems: Dysuria; Urinary Frequency / Polyuria

  MAUDE report 22126939 ↗
• InjuryJun 2, 2025Premature Discharge of Battery; Premature Discharge of Battery

  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   PREVIOUS INS BATTERY DID NOT LAST AS LONG AS THEY EXPECTED. THEY STATED THAT THEY FIRST NOTICED THE ISSUE THE OTHER DAY. THE PATIENT STATED THAT MDT REPS ALWAYS COME IN AND SAY THAT THEIR INS BATTERY IS GOING TO LAST TEN YEARS OR WHATEVER, BUT BECAUSE THEY HAD IT IN 2010 TO START, THEY HAD THE STIMULATION UP TOO HIGH BACK THEN, SO IN 4 YEARS THEIR INS BATTERY DEPLETED. THE PATIENT ALSO MENTIONED UNRELATED MEDICAL HISTORY THAT THEY WERE A LOT HEAVIER BACK THEN. THE PATIENT ADDED THAT THE MDT REPS DON'T TAKE INTO CONSIDERATION ANY OF THE OTHER FACTORS THAT CAN IMPACT HOW LONG IT LASTS .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125729 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970004. One submission often covers many models, so check the product and lot details in each record.

• 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-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