INTERSTIM® 3889-28 (UDI 00613994752420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994752420), received between Nov 29, 2016 and May 23, 2022 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REP REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. THE REASON FOR CALL WAS CALLER STATED NORMAL REPLACEMENT/UPGRADE TO MRI FULL BODY COMPATIBILITY SYSTEM WAS PLANNED. HOWEVER, DURING REMOVAL OF THE 3889 LEAD, THE LEAD SNAPPED AND THEREFORE, THE ELECTRODES REMAIN IMPLANTED. CALLER STATED THE NEW LEAD WAS SUCCESSFULLY PLACED ON THE CONTRALATERAL SIDE. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. CALLER STATED PRODUCT WAS DISCARDED AND REQUESTED THAT THE DOCTOR NOT RECEIVE ANY FOLLOW-UP. TSS REVIEWED THAT FULL BODY SYSTEM WITH THE PRESENCE OF AN ABANDONED COMPONENT HAS NOT BEEN TESTED, IS NOT ADDRESSED IN LABELING AND THEREFORE, THEY CANNOT SPEAK TO MRI COMPATIBILITY FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469913 ↗
• MalfunctionMar 28, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE CALLER REPORTED THE PATIENT IS NEEDING MRI. THE PATIENT HAD INS EXPLANTED BUT PART OF LEAD REMAINS IMPLANTED BECAUSE "THEY WERE NOT ABLE TO PULL IT ALL OUT", CALLER UNABLE TO CLARIFY FURTHER. TSS OFFERED TO TRANSFER CALLER TO MEDICAL AFFAIRS - CALLER DECLINED. REVIEWED MRI LABELING DOES NOT SUPPORT SCANNING PTS WITH ABANDONED COMPONENTS

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13929000 ↗
• MalfunctionMar 2, 2022Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A FULL SYSTEM REPLACEMENT AND UPON INITIAL X-RAY IT WAS REVEALED THAT NOT ONLY DID THE PATIENT HAVE TWO SYSTEMS BUT TWO ABANDONED LEADS AS WELL. THE LEADS ALSO CROSSED THE SACRUM AND WERE ON OPPOSITE SIDES OF THE BATTERY. ATTEMPTED REMOVAL OF THE LEAD CAUSED A FRACTURE AS IT WAS IMPLANTED DEEP AND ANOTHER LEAD WAS LEFT ABANDONED. THERE ARE CURRENTLY TWO FULL SYSTEMS AND NOW A TOTAL OF 3 ABANDONED LEADS. THERE IS NO RECORD OF THE TWO PREVIOUS GHOST LEADS AND WHY THEY WERE ABANDONED. LEADS WERE IMPLANTED DEEP BUT DURING INTRO OP TESTING THE PATIENT'S MOTOR RESPONSES WERE ALSO DEEP. ATTEMPTS WERE MADE TO REMOVE THE LEADS BUT WERE UNSUCCESSFUL. PATIENT WAS IMPLANTED WITH TWO SYSTEMS IN 2014 AND 2015. THE PLAN WAS A SCHEDULED REMOVAL OF ONE SYSTEM. A NEW SYSTEM WAS IMPLANTED. THE REMAINING SYSTEM HAS 5-17 MONTHS BATTERY LIFE AND AT THAT TIME WILL BE A SIMPLE BATTERY REPLACEMENT. THE PATIENT CURRENTLY HAS TWO FULL SYSTEMS AND 3 ABANDONED LEADS.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 13653539 ↗
• InjurySep 28, 2021Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT PATIENT HAD THE STIMULATOR REMOVED LAST YEAR BUT THE DOCTOR DIDN'T GET ALL OF THE LEAD REMOVED. PATIENT WANTED TO KNOW IF SHE COULD GET AN MRI. EXPLAINED IT IS NOT RECOMMENDED WITH PART OF THE SYSTEM LEFT IN THE BODY. PATIENT GOT UPSET AND HUNG UP.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12538421 ↗
• MalfunctionJul 6, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; 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) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE LEAD BROKE DURING REMOVAL, JUST THE ELECTRODES WERE LEFT AFTER THE PATIENT TRIED DIGGING DOWN INTO THE SACRUM TO RETRIEVE THE FRAGMENTED LEAD. IT WAS NOTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12120631 ↗
• MalfunctionMar 4, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE 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 THE LEAD WAS BEING REMOVED TO BE REPLACED SO THAT THE PATIENT COULD GET AN MRI AND IT SNAPPED IN HALF DURING EXPLANTATION. MULTIPLE ATTEMPTS AND FURTHER EXPLORATION TO REMOVE THE LEAD WERE PERFORMED, BUT THEY WERE UNABLE TO RECOVER THE ELECTRODES FROM THE END OF THE LEAD. AT THE TIME OF THE REPORT IT WAS INACTIVE BUT STILL PRESENT IN THE BODY.  IT WAS REPORTED THAT FURTHER SURGERY WAS REQUIRED TO GET IT OUT OF THE PATIENT. THE DOCTOR HAD DISSECTED DOWN TO THE SACRUM AND SPENT A LONG TIME USING FLUOROSCOPY AND VISUAL/TACTILE METHODS TO TRY TO GET THE LEAD OUT COMPLETELY. THEY WERE UNABLE TO REACH THE LEAD WITHOUT ADDITIONAL HELP/INTERVENTION BY A DIFFERENT/NEURO SPECIALIST BECAUSE IT WAS TOO DEEP IN THE SACRUM. THE PATIENT WAS CLOSED WITHOUT COMPLETE REMOVAL OF THE LEAD ELECTRODES. AS OF NOW THE REP WAS UNAWARE OF ANY ADDITIONAL FOLLOW-UP APPOINTMENT FOR THE PATIENT. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11411766 ↗
• InjuryNov 26, 2020Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THEIR DEVICE STOPPED HELPING WITH SYMPTOMS. THE WIRES CORRODED AND HAD TO BE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 10907689 ↗
• MalfunctionNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 DURING A FULL SYSTEM REPLACEMENT  LEAD FRAGMENTED. PARTIALLY REMAIN IN PATIENT¿S SACRUM. THE CAUSE WAS UNKNOWN. FLUOROSCOPY WAS USED TO LOCATE THE LEAD. HCP TRIED UNSUCCESSFULLY TO REMOVE THE FRAGMENTED LEAD.  NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10835762 ↗
• MalfunctionNov 10, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  PATIENT NEEDS A SCAN OF THE BACK, KIDNEY'S AND STOMACH BUT THE NEW DEVICE SHOWED THE PATIENT IS NOT ELIGIBLE FOR FULL BODY SCAN DO TO ABANDON PRODUCT. PATIENT SAID THAT HER DOCTOR DID HAVE TO LEAVE PART OF THE LEAD IN BECAUSE IT ADHERED TO THE BONE. PATIENT WAS UPSET BECAUSE THE WHOLE REASON THEY GOT THE NEW SYSTEM WAS SO THEY COULD GET AN MRI. THE PATIENT WAS ADVISED TO CONSULT WITH THEIR DOCTOR AND TO HAVE THE DOCTOR CONSULT WITH TECHNICAL SUPPORT REGARDING THE RISKS WITH MRI DUE TO LEAD REMNANT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10815921 ↗
• MalfunctionNov 4, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THE LEAD FRACTURED UPON REMOVAL. THE LEAD WAS EXTRACTED FROM THE LEAD INSERTION SITE USING PROPER TECHNIQUE. CONTRIBUTING FACTORS WERE UNKNOWN. THE ELECTRODES REMAINED IN THE SACRUM. A NEW SYSTEM WAS IMPLANTED WITH NO ISSUES. IT WAS NOTED THE ISSUE WAS RESOLVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10784230 ↗
• InjuryJul 15, 2020Energy Output Problem; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THERE WAS A REPLACEMENT SURGERY ON CONTRALATERAL SIDE WAS PERFORMED DUE TO INEFFECTIVE STIMULATION. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10277844 ↗
• MalfunctionJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE INS AND LEAD WERE EXPLANTED ON (B)(6) 2020 BUT THE DISTAL TIP AND 4 ELECTRODES BROKE OFF BELOW THE SACRUM AND ARE STILL IMPLANTED. PER THE CALLER (MRI TECH), THE PATIENT A ND HUSBAND WERE NOTIFIED OF THE ISSUE. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10168531 ↗
• InjuryMay 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT IN (B)(6) 2019, SHE STARTED EXPERIENCING A LOW OF BLADDER INFECTIONS AND A FEW MONTHS AGO, SHE FOUND OUT HER LEADS WERE "BLOCKING OUT" ON HER. THE CALLER BELIEVES SHE IS GETTING THESE BLADDER INFECTION BECAUSE HER LEADS ARE NOT FUNCTIONING PROPERLY. THE CALLER MENTIONED THAT HER LEADS HAVE "BLOCKED OUT" ON HER A COUPLE OF TIMES AND THE HEALTHCARE PROFESSIONAL HAS HAD TO REPROGRAM THE DEVICE TO USE THE LEADS THAT WERE NOT BLOCKED. THE CALLER STATED THAT SHE HAS 2-3 BLOCKED; PATIENT SERVICES BELIEVES SHE IS REFERRING TO HER ELECTRODES BUT THE CALLER COULD NOT CONFIRM. THE CALLER STATED SHE HAS GOTTEN 2 OPINIONS (UROLOGIST AND GYNO; MANAGING HEALTHCARE PROFESSIONAL) AND THE UROLOGIST IS NERVOUS ABOUT THE DEVICE AND WANTED IT REPLACED WHILE HER MANAGING HEALTHCARE PROFESSIONAL SAID EVERYTHING IS OK AND DID NOT WANT TO REPLACE IT. HER MANAGING HEALTHCARE PROFESSIONAL DOES NOT WANT TO REPLACE IT BECAUSE THE INS BATTERY/LONGEVITY IS GOOD. THE CALLER MENTIONED THAT SHE USED TO WORK WITH

  Patient problems: Anxiety; Urinary Tract Infection

  MAUDE report 10039206 ↗
• MalfunctionMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS AN IN-HOUSE FINDING WITH NO DEVICE ALLEGATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9856980 ↗
• MalfunctionDec 11, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT DURING REMOVAL OF THE LEAD FROM POCKET SITE, THE LEAD BROKE OFF. THE LEAD WAS PARTIALLY EXPLANTED SO A PORTION REMAINS IN THE PATIENT'S BODY. THE LEAD WAS REPLACED AND NO FURTHER COMPLICATIONS ARE ANTICIPATED OR REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9451135 ↗
• InjuryDec 14, 2018Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S LEAD. THE REP CONFIRMED THAT THE LEAD ISSUE HAPPENED WHILE THE HCP WAS TRYING TO DRY OFF THE ORIGINAL LEAD. A PLAN WAS MADE FOR RETURN OF THE LEAD FOR ANALYSIS. WHEN ASKED WHETHER A DEFINITIVE CAUSE OF THE LEAD ISSUE WAS DETERMINED, THE REP STATED: THEY COULD ONLY ASSUME THAT THE GLUED SECTION ON THE HEADER ELECTRODES WEAKENED SINCE IT WAS IMPLANTED IN 2013 AND LOST THE ABILITY TO STAY INTACT WHEN BEING GENTLY WIPED OFF. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8165131 ↗
• MalfunctionFeb 16, 2018Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED BECAUSE IT WENT BAD. THE PATIENT STATED THAT AFTER HER EXPLANT, HER CHILDREN WERE TOLD THAT THE LEAD WIRE HAD BROKEN. THE PATIENT INQUIRED WARRANTY INFORMATION AND IT WAS REVIEWED. IT WAS STATED THAT SINCE THE WHOLE SYSTEM WAS REMOVED, THE PATIENT'S BLADDER WAS WORSE THAN BEFORE SHE GOT THE DEVICE. THE PATIENT STATED THAT WHEN SHE WASN'T HAVING ISSUES WITH THE DEVICE, SHE LOVED IT AND IT SAVED HER MONEY ON DEPENDS/DIAPERS AND SHE DIDN¿T HAVE TO GO TO THE BATHROOM ALL THE TIME OR WET HERSELF. THE PATIENT INQUIRED ABOUT GETTING ANOTHER SYSTEM IMPLANTED AND INFORMATION WAS REVIEWED. THE PATIENT SAID THE HCP INFORMED HER FAMILY THAT THE LEAD BROKE AT THE EXPLANT SURGERY A COUPLE WEEKS AGO. NO FURTHER COMPLICATIONS WERE INDICATED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7278449 ↗
• MalfunctionNov 29, 2016Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PROCEDURE. IT WAS REPORTED THAT THE LEAD WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. THE DOCTOR FOUND THAT THE INSULATION WAS BROKEN WHEN HE TRIED TO IMPLANT THE LEAD. THE CURVED STYLET WAS INSERTED INTO THE LEAD PRIOR TO IMPLANTATION. A NEW LEAD WAS OPENED AND IMPLANTED SUCCESSFULLY. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6133223 ↗

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