InterStim™ 3560022Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000203894), received between Aug 20, 2020 and Nov 19, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT EXTENSION FAILURE. THE EXTENSION DID NOT CAUSE ANY SENSATION OF IRRITATION. IT WAS REPLACED. ISSUE RESOLVED. WILL BE RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 23595553 ↗
• MalfunctionOct 31, 2025Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING PROCEDURE, THE LEAD DID NOT GO INTO THE PERCUTANEOUS EXTENSION CABLE. IT TURNED OUT THAT THE SCREW WAS INSIDE AND BLOCKING LEAD ENTRANCE. CAUSE NOT SPECIFIED. SCREW WAS TAKEN OUT AND IT WAS SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437410 ↗
• MalfunctionDec 10, 2024Component Missing; Insufficient Device Problem Information; Component Missing; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WAS A DEFECT WITH THE PERCUTANEOUS EXTENSION. IT WAS NOTED THAT THE PERCUTANEOUS EXTENSION CONNECTOR DID NOT HAVE A SET SCREW. THE CAUSE WAS NOT KNOWN. A DIFFERENT PERCUTANEOUS EXTENSION WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892450 ↗
• InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE TRIAL PATIENT STARTED THEIR TRIAL ON (B)(6) 2024. THE PATIENT HAS VISITED THEIR ABDOMINAL SURGEON FOR REGULAR VISIT FOR CHECKING THE WOUNDS AND THE WOUND MANAGEMENT. AFTER CHECKING THE PATIENT'S SKIN THERE WAS URTICARIA AND INITIAL SYSTEMIC URTICARIA, AND EDEMA ON PARTS OF THE SKIN WHERE THE EXTENSION WAS IN DIRECT CONTACT. THE DOCTOR ASSUME IT COULD BE AN ALLERGIC REACTION TO THE PERCUTANEOUS EXTENSION MATERIALS. THEY DID SKIN OBSERVATION, ANTI-ANAPHYLACTIC MEASURES, AND PATIENT HAD BEEN SENT TO OR TO IMMEDIATE REMOVAL/EXPLANTATION OF THE EXTENSION AND WAS TREATED ANTI-ANAPHYLACTIC. FURTHER DERMATOLOGY EXAMINATIONS ARE SCHEDULED ALLERGY TESTS TO SPECIFIC MATERIALS ARE SCHEDULED. THE PATIENT IS HEMODYNAMIC STABILE ALL THE TIME. THEY ARE AWAITING TO SEE IF THE PATIENT IS GOING TO BE SUITABLE FOR PERMANENT IMPLANTATION OF THE PERMANENT IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT IS OK AND WILL BE HOSPITALIZED UNTIL NEXT WEEK DUE TO URTICARIA SYMPTOM

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Rash; Swelling/ Edema; Unspecified Infection; Urticaria

  MAUDE report 19646174 ↗
• MalfunctionMay 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING TRIAL CONVERSION, THE BARREL CONNECTOR ON THE PERCUTANEOUS EXTENSION WAS CUT FROM THE EXTENSION SO THAT THE EXTERNAL PORTION COULD BE REMOVED BY NON-SCRUB HOSPITAL PERSONNEL. AFTER DISCARDING THE BARREL CONNECTOR, THE SURGEON FOUND A SMALL PIECE OF PLASTIC TUBING IN THE POCKET WOUND, PRESUMABLY FROM THE PERCUTANEOUS EXTENSION. SURGEON RETRIEVED SMALL PIECE OF PLASTIC TUBING FROM THE WOUND AND DISCARDED IT. THE SURGEON IS CONCERNED THAT IF A SMALL PIECE OF PLASTIC IS INADVERTENTLY LEFT IN THE POCKET WOUND THEN THE PATIENT WILL BE AT A HIGHER RISK OF INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261130 ↗
• InjuryMar 8, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT REGARDING EXTENSION LOT# VA2W455, ACCORDING TO THE DOCTOR, THE LEADS ON THE INSULATION ARE DEFECTIVE AND THEREFORE NO CONNECTION COULD BE ESTABLISHED TO THE ELECTRODES. A REVISION OPERATION IS SCHEDULED FOR (B)(6). MORE INFORMATION WILL FOLLOW AFTER THE REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18870772 ↗
• MalfunctionAug 30, 2023Connection Problem; Insufficient Device Problem Information; Connection Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED AN EXTENSION MALFUNCTION AND THAT THE LEAD WOULD NOT PASS INTO THE CONNECTOR OF THE EXTENSION EVEN AFTER BACKING THE SCREW OUT AND MULTIPLE ATTEMPTS. THE EXTENSION WAS REPLACED AND WILL BE RETURNED. ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653355 ↗
• MalfunctionAug 20, 2020Component Missing; Component Missing

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE: PATIENT WEIGHT 318 POUNDS (PREVIOUSLY REPORTED AS 308 PO UNDS). ***MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTS REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10432982 ↗

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