INTERSTIM® 3889-33 (UDI 00643169864443)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169864443), received between Aug 24, 2018 and Nov 12, 2020 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED BACK PAIN STARTING FROM THE 'DEVICE CLOSEST' TO THEIR SPINE AND GOES TO THE HIP ON THE OPPOSITE SIDE. THEY STATED A NON-MANAGING PHYSICIAN TOOK AN X-RAY AND STATED THE 'WIRE' WAS ON THE OPPOSITE SIDE OF THE BODY THAN WHERE IT WAS IMPLANTED. THE PATIENT CALLED THE MANAGING PHYSICIAN WHO TOLD THEM TO TURN STIMULATION OFF. THEY PAIN WENT DOWN A LITTLE BUT, BUT NOT MUCH. THE PATIENT HAS NOT HAD FALLS OR TRAUMA, BUT DRIVES A TRACTOR TRAILER (STATED THEY WENT BACK TO WORK THE WEEK OF IMPLANT SURGERY. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.  NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: Pain

  MAUDE report 10830616 ↗
• MalfunctionJun 29, 2020Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PHYSICIAN AND REP WAS NOT SURE BUT AGREED THE MOST LIKELY POSSIBILITY IS THE PROXIMAL LEAD TIP WAS DAMAGED WHILE CLASPING THE LEAD INTO THE CURVED STYLET. THE PHYSICIAN CHOSE TO CONTINUE WITH THE ADVANCED EVALUATION. THE PATIENT THEN RETURNED AND HAD A SUCCESSFUL INS IMPLANT. THE PATIENT HAD A PHENOMENAL CLINICAL RESPONSE AT 0.5 MA THROUGHOUT THE TRIAL. THE PHYSICIAN DID NOT TAKE ANY STEPS TO TRY AND FURTHER ALTER THE LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10206358 ↗
• InjuryMar 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY A HEALTHCARE PROFESSIONAL VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THEIR LEAD HAD ERODED THROUGH THEIR SKIN. IT WAS DIAGNOSED THROUGH VISIBLE EXAMINATION. REMOVAL WAS SCHEDULED. NO DEVICE ISSUE ALLEGED / IDENTIFIED. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: Erosion

  MAUDE report 9774012 ↗
• MalfunctionJan 31, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY. IT WAS REPORTED THAT THEY THOUGHT THEIR LEADS MIGHT HAVE MOVED. THEY WERE ADVISED TO CONTACT THEIR CLINICIAN. NO FURTHER DEVICE ISSUE ALLEGED / IDENTIFIED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9652811 ↗
• MalfunctionAug 20, 2019Break; Device Contamination with Chemical or Other Material; Positioning Problem; Break; Device Contamination with Chemical or Other Material; Positioning Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO HAD AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WAS PLACED ON THE LEFT SIDE HOWEVER THEY WERE NOT ABLE TO GET ANY MOTOR OR SENSORY RESPONSE ON ANY ELECTRODES. THE LIVE FLUOROSCOPY SHOWED THAT THE TIP OF THE LEAD WAS HITTING SOMETHING BECAUSE IT WAS CURLING UP. THE HEALTHCARE PROFESSIONAL (HCP) RELOADED THE LEAD TRYING TO STEER IT TO THE CORRECT POSITION BUT AFTER TESTING AGAIN MULTIPLE TIMES, HCP DECIDED TO TRY THE LEFT SIDE. UPON LOADING THE LEAD INTO THE INTRODUCER HCP NOTICED THERE WAS BLOOD INSIDE THE LEAD. AT THAT POINT HCP REALIZED IT WAS BROKEN AFTER ELECTRODE 0. A NEW LEAD WAS LOADED AND ALL CORRECT SENSORY AND MOTOR RESPONSES WERE ACHIEVED. LEAD WILL BE RETURNED BACK TO MEDTRONIC. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8912215 ↗
• InjuryJul 9, 2019Break; Device Damaged Prior to Receipt by User; Human-Device Interface Problem; Break; Device Damaged Prior to Receipt by User; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT DURING IMPLANT THE SURGEON WAS ATTEMPTING TO PLACE THE LEAD AND HAVING TROUBLE. THE HCP NOTICED THE LEAD WAS PUNCTURED RIGHT ABOVE THE ELECTRODES AND THEY HAD TO USE A DIFFERENT LEAD. THE REP REPORTED THE ISSUE WAS OCCURRING OUT OF THE BOX. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 2019-JUN-25 FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) INDICATING THAT THE ISSUE OCCURRED DURING AN ADVANCED EVALUATION PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Effects, Unexpected

  MAUDE report 8772568 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (IN S) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT'S INCISION OPENED AND THE LEAD WAS EXPOSED THROUGH THE INCISION. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2019 AND THE EXPOSED WIRE WAS REPORTED ON (B)(6) 2019. IT WAS NOTED THIS WAS OBSERVED BY THE PATIENT AND THEIR FRIEND AND THE DOCTOR'S OFFICE HAD BEEN CONTACTED. IT WAS REPORTED THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER VIA THE MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THEY GOT AN UPDATE FROM THE PHYSICIAN, DERMABOND GLUE COVERING THE LEAD/SKIN INCISION OPENED UP AND PART OF THE LEAD WAS EXPOSED. THE PATIENT WAS SEEN THE WEDNESDAY PRIOR IN THE PHYSICIAN'S OFFICE, THE INCISION WAS CLOSED AGAIN WITH A SUTURE AND 2 DAYS OF KEFLEX WAS INITIATED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 8240919 ↗
• MalfunctionDec 6, 2018Positioning Problem; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THERE WAS DIFFICULTY PLACING THE LEAD IN THE ORIGINAL, STAGE 1 PROCEDURE AND IT TOOK APPROXIMATELY 2 HOURS. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137298 ↗
• MalfunctionAug 24, 2018Break; Peeled/Delaminated; Break; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP): THE LEAD WAS NEVER IMPLANTED, THE PROTECTIVE COATING SEPARATED PRIOR TO IMPLANT AND THE LEAD WAS REPLACED/NEW LEAD WAS USED. IT WAS CLARIFIED THAT THE LEAD SEPARATED WHEN PLASTIC SNAP ON END OF STYLETTE WAS REMOVED FROM THE PROXIMAL END OF THE LEAD. THERE WAS NO PATIENT INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812515 ↗

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