InterStim Therapy System, Verify Evaluation System

• • Ongoing Z-1704-2025 FDA Class II ·initiated 3 Apr 2025 ·on shared PMA P080025

  Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

• • Ongoing Z-0372-2025 FDA Class II ·initiated 18 Sep 2024 ·on shared PMA P080025

  The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

• • Ongoing Z-2365-2023 FDA Class II ·initiated 6 Jul 2023 ·on shared PMA P080025

  Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

• • Terminated Z-0998-2022 FDA Class II ·initiated 28 Feb 2022 ·on shared PMA P080025

  There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.

• • Terminated Z-1147-2015 FDA Class II ·initiated 9 Jan 2015 ·on shared PMA P080025

  Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Medtronic Interstim Sacral Nerve Stimulation Therapy System

Generic Name

Implanted electrical device intended for treatment of fecal incontinence

PMA Number

P080025 ↗

FDA Product Code

QON

Device Class

Class III

Regulation

21 CFR Part 876.5270

Advisory Committee

Gastroenterology, Urology

FDA Decision

APPR Approved

• SureTune4 Software

  Class II

  FDA De Novo DEN210003 Active Cleared 23 Aug 2021 FDA 510(k)

• Altaviva System

  Class III

  FDA PMA P240011 Active Approved 18 Sep 2025

• Interstim Therapy System for Urinary Control Open recall

  Class III

  FDA PMA P970004 Active Approved 29 Sep 1997

• Itrel, Synergy and Intellis Spnal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead Open recall

  Class III

  FDA PMA P840001 Active Approved 30 Nov 1984

• What is the primary clinical purpose of the InterStim Therapy System, and who is it designed for?

  The InterStim Therapy System is designed to treat chronic fecal incontinence in patients who have not responded to or cannot tolerate conservative treatments. It uses sacral nerve stimulation to modulate nerve signals, helping improve bowel control and reduce incontinence episodes. This system is intended for use in clinical settings by trained healthcare professionals and requires surgical implantation.

• How is the InterStim Therapy System supplied, and is it intended for single-use or reusable applications?

  The InterStim Therapy System is supplied as a reusable medical system, including both implantable and external components such as a pulse generator and leads. Unlike single-use devices, this system is intended for long-term use after surgical implantation, requiring maintenance and potential adjustments by healthcare professionals over time.

• What role does the Verify Evaluation System play in the InterStim Therapy process, and how does it differ from the main therapy system?

  The Verify Evaluation System is used for patient screening before permanent implantation of the InterStim Therapy System. It allows clinicians to test the effectiveness of sacral nerve stimulation on an individual patient before committing to full implantation, ensuring the therapy will provide benefit before permanent placement of the device.

• Is the InterStim Therapy System regulated under a specific FDA pathway, and what does that mean for clinicians?

  Yes, the InterStim Therapy System is regulated under the FDA’s Premarket Approval (PMA) pathway (PMA number P080025), classified as a Class III device (QON). This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in treating chronic fecal incontinence, providing clinicians with confidence in its regulatory standing.

• Which medical specialties are primarily involved in the use and oversight of the InterStim Therapy System?

  The InterStim Therapy System is primarily overseen and utilized by specialists in **Gastroenterology** and **Urology**, as indicated by its advisory committee classification. These specialties are key in managing patients with chronic fecal incontinence and determining whether sacral nerve stimulation is an appropriate treatment option.