INTERSTIM® 3889-33 (UDI 00643169887930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169887930), received between Mar 29, 2018 and Jan 12, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2021Break; High impedance; Device Contamination with Chemical or Other Material; Break; High impedance; Device Contamination with Chemical or Other Material

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE REP REPORTED THERE WAS BLOOD IN THE INNER INSULATION OF THE LEAD. THERE WERE NO KNOWN CONTRIBUTING FACTORS. THE IMPEDANCES WERE HIGH AND BLOOD WAS SEEN; THE LEAD WAS REPLACED AS THE INSULATION WAS BREACHED. IT WAS NOTED THE ISSUE WAS RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154741 ↗
• MalfunctionJan 3, 2020Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT NO CAUSE WAS INDICATED BY THE PHYSICIAN. THE EVENT OCCURRED DURING REMOVAL OF THE LEAD. THE LEAD WAS SOMEWHAT DIFFICULT TO REMOVE, AND THE LEAD UNRAVELED DURING THE PROCESS OF EXERTING TRACTION TO REMOVE THE LEAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9545843 ↗
• InjuryJan 2, 2019Break; Migration or Expulsion of Device; Insufficient Device Problem Information; Break; Migration or Expulsion of Device; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WOULD NOT DEPLOY THE TINES AND THEREFORE IT WAS SLIPPING. A NEW LEAD WAS OPENED AND USED FOR THE CASE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209609 ↗
• MalfunctionMar 29, 2018Unsealed Device Packaging; Unsealed Device Packaging

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR UNKNOWN INTERSTIM THERAPY. IT WAS REPORTED THAT THE LEAD¿S STERILE PACKAGING WAS OPENED IN THE OR AND THE LEAD EXTENSION WIRE WAS INSIDE THE GLUED AREA. STERILITY COULD NOT BE GUARANTEED. THEREFORE, A NEW LEAD WAS OPENED AND USED FOR IMPLANTATION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7381604 ↗

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-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