INTERSTIM 3889-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994601957), received between Nov 18, 2016 and May 31, 2017 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS. PROGRAMMING CHANGES WERE MADE AT THE OFFICE AND THERE WERE NO NOTED ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT CONTRIBUTED TO THE ISSUE. THE PATIENT HAD A LEAD REVISION AND THE PRODUCT WAS EXPLANTED. IT WAS INDICATED THAT THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR WERE EXPECTED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 6601460 ↗
• MalfunctionFeb 6, 2017Break; Break

  NO NEW INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6303614 ↗
• InjuryJan 20, 2017Migration or Expulsion of Device; Unintended Collision; Incorrect, Inadequate or Imprecise Result or Readings; Device Operates Differently Than Expected; Impedance Problem; Migration or Expulsion of Device; Unintended Collision; Incorrect, Inadequate or Imprecise Result or Readings; Device Operates Differently Than Expected; Impedance Problem

  INFORMATION WAS RECEIVED FROM A PATIENT VIA A COMPANY REPRESENTATIVE (REP). IT WAS REPORTED THAT PATIENT FOLLOWED UP IN OFFICE AND REPORTING THAT SYSTEM WAS NOT WORKING. THERE WERE ABNORMAL IMPEDANCES NOTED DURING INTERROGATION BY OFFICE STAFF. THEY WERE UNABLE TO OBTAIN BATTERY LIFE STATUS DURING INTERROGATION. PATIENT REPORTED THAT SHE HAD FALLEN A COUPLE TIMES AND FELL ON UNIT. THE DEVICE HAD NOT WORKED WELL SINCE. THE IMPLANTABLE NUEROSTIMULATOR (INS) BATTERY WAS ALSO VERY LOOSE IN THE POCKET. THE FULL SYSTEM REPLACEMENT OCCURRED ON (B)(6) 2017. THE ISSUE WAS RESOLVED AT TIME OF THE REPORT. PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6266232 ↗
• MalfunctionJan 18, 2017Break; Break

  PRODUCT ANALYSIS IS AVAILABLE NOW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6260570 ↗
• MalfunctionNov 18, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED A STIMULATED LEAD DID NOT PROVIDE MOTOR RESPONSE DURING A PROCEDURE AND FELT THERE MAY BE FAULT WITH THE LEAD. WHEN TESTED WITH THE TEST STIMULATION CABLE, THE LEAD DID NOT PROVIDE A MOTOR RESPONSE. THERE WAS A LARGE AMOUNT OF BLOOD SURROUNDING THE ELECTRODES ON THE LEAD, WHICH MAY HAVE INHIBITED THE STIMULATION OF THE LEAD. TROUBLESHOOTING WAS NOTED AS FORAMEN NEEDLE PLACED INTO LEFT S4 FORAMEN AND TESTING WITH THE TEST STIMULATION CABLE PROVIDED A MOTOR RESPONSE. THE LEAD IN QUESTION WAS THEN IMPLANTED INTO THE LEFT S4 FORAMEN WITH NO MOTOR RESPONSE WHEN TESTED. FORAMEN NEEDLE INSERTED INTO RIGHT S4 FORAMEN AND TESTING WITH THE TEST STIMULATION CABLE PROVIDED A MOTOR RESPONSE. LEAD INTRODUCER/SHEATH DILATOR INSERTED INTO RIGHT S4 FORAMEN AND A LARGE AMOUNT OF BLOOD CAME THROUGH THE SHEATH ONCE THE DILATOR WAS REMOVED. DILATOR REINSERTED AND LEAD INTRODUCER WAS SLIGHTLY MOVED THE MINIMIZE BLOOD FLOW. ONCE BLOOD FLOW HAD CEASED THE LEAD WAS INSERTED AND THERE WAS NO MOTOR RESPONSE WHEN TESTED. NO FURTHER ACTIONS WERE TAKEN AS A HEMATOMA WAS FORMING AND THE SURGEON REMOVED THE LEAD, AND CEASED PROCEDURE. THE

  Patient problems: Hematoma; Therapeutic Effects, Unexpected

  MAUDE report 6112988 ↗

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