INTERSTIM® 3889-33 (UDI 00643169651128)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169651128), received between Jan 19, 2017 and Jan 2, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2018Device Operates Differently Than Expected; Positioning Problem; Device Operates Differently Than Expected; Positioning Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL STIMULATION, BOWEL DYSFUNCTION/SACRAL NERVE STIMULATION, FECAL INCONTINENCE, AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT DURING INTRA-OPERATION THERE WAS LEAD STEERING DIFFICULTY. THE REP STATED THAT THERE WAS NO PRODUCT DAMAGED CAUSED OR DISCOVERED DURING THE PROCEDURE AND NO TROUBLE SHOOTING WAS CONDUCTED DUE TO LACK OF ACCESS TO THE PRODUCT. IT WAS NOTED THAT THE DOCTOR WAS HAVING TROUBLE GETTING THE LEAD INTO POSITION AND IT WASN'T PICKING ANYTHING UP SO THE DOCTOR WANTED A DIFFERENT LEAD. THE REP REPORTED THAT THE CASE WAS FINISHED SUCCESSFULLY WITH A DIFFERENT LEAD. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7157060 ↗
• InjuryJul 19, 2017Break; Break

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE ELECTRODES ON THE LEAD WERE DAMAGED BY SHEARING FORCE WHEN THE DILATOR WAS BEING REPOSITIONED. THE ISSUE WAS SURGEON-RELATED. NO COMPONENTS OF THE DAMAGED LEAD REMAINED IN THE PATIENT. A NEW LEAD WAS THEN USED AND THE ISSUE WAS REPORTED AS RESOLVED. THE DAMAGED LEAD WAS DISCARDED BY THE CUSTOMER. THE PATIENT STATUS WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724345 ↗
• MalfunctionJan 19, 2017Break; Break

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT THE LEAD CAME APART AT THE PROXIMAL END, THE R EP NOTED IT SHREDDED FROM THE PLASTIC COVERING. THE REP STATED THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE THAT THEY OBSERVED. THE REP NOTED THE LEAD WAS REPLACED WITH A FULL FUNCTIONING LEAD AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE PATIENT IS IMPLANTED FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6264695 ↗

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