InterStim™ 3560030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000203887), received between Jul 29, 2020 and Mar 9, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (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.

• InjuryMar 9, 2021Human-Device Interface Problem; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERGOING AN IMPLANT PROCEDURE FOR AN ADVANCED EVALUATION WITH AN EXTERNAL NEUROSTIMULATOR. IT WAS REPORTED THAT AN 3536030 EXTENSION WAS OPENED BY THE CIRCULATOR AND GIVEN TO THE SURGICAL TECH. BOTH THE 3560030 (INCORRECT PRODUCT) AND THE 3560022 (CORRECT PRODUCT) WERE IN THE ROOM AND THE INCORRECT PRODUCT WAS OPENED AND USED BY THE MISTAKE. THE DOCTOR SUBSEQUENTLY ATTACHED THE EXTENSION TO A 978B128 LEAD. THE REP SAW THE HCP TIGHTEN THE SET SCREW WITH THE HEX WRENCH AND PROCEEDED TO CLOSE THE INSERTION SITE. THE PATIENT WAS THEN BANDAGED AND TAKEN TO RECOVERY. WHILE REVIEWING THE PAPERWORK IMMEDIATELY AFTER THE CASE, THE REP NOTICED THAT THE INCORRECT EXTENSION HAD BEEN USED DURING THE CASE. THE REP NEVER NOTICED ANY ISSUE DURING THE CASE. THE REP NOTIFIED THE DOCTOR AND STAFF IMMEDIATELY AND THE PATIENT WAS BROUGHT BACK INTO THE OPERATING ROOM FROM RECOVERY AND THE INCORRECT EXTENSION WAS REPLACED WITH THE CORRECT ONE (3660022) WITHOUT INCIDENT. THIS PATIENT IS UNDERGOING AN TRIAL FOR URINARY INCONTINENCE. THE PATIENT WAS DOING VERY WELL DURING THE TRIAL AND I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445607 ↗
• InjuryNov 3, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IM PLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PERCUTANEOUS EXTENSION FROM THE STAGE 1 TRIAL MIGRATED TOWARDS THE CONTRALATERAL EXIT SITE. IT WAS DIFFICULT TO PULL THE PERC EXTENSION BACK TO THE POCKET INCISION TO RELEASE THE BOOT AND CONNECT THE INS. NO CONTRIBUTING FACTORS WERE KNOWN. THEY HAD TO MAKE A LARGER PATH TO PULL THE PERC EXTENSION BACK TO THE POCKET SITE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10780259 ↗
• InjuryJul 29, 2020Migration or Expulsion of Device; Human-Device Interface Problem; Migration or Expulsion of Device; Human-Device Interface Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA THE MANUFACTURER REPRESENTATIVE REPORTING MIGRATION OF THE EXTENSION DURING THE IMPLANT PROCEDURE. THE SURGEON HAD DIFFICULTIES TO CATCH THE CONNECTION AND HAD TO OPEN IN THE MIDDLE OF THE BACK TO GET THE EXTENSION. THIS CAUSED EXTENDED SURGERY TIME OF 25 MINUTES. THE TUNNELING PATH WAS ABOUT 20 CM AND A DILATOR TIP WAS USED FOR TUNNELING. THERE WAS NO PROBLEM WITH THE CONNECTION. THREE COILS OF THE EXTENSION WERE PLACED UNDER THE POST-OP BANDAGE/DRESSING. THE COILS WERE STILL IN PLACE ONCE THE PATIENT RETURNED AFTER THE EVALUATION. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10338202 ↗

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