Interstim Therapy System for Urinary Control

• • Ongoing Z-0372-2025 FDA Class II ·initiated 18 Sep 2024 ·on shared PMA P970004

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

• • Terminated Z-0998-2022 FDA Class II ·initiated 28 Feb 2022

  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 P970004

  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.

• • Terminated Z-0037-2008 FDA Unclassified (pre-2012) ·initiated 25 Jun 2007

  A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant .

• • Terminated Z-0040-2008 FDA Unclassified (pre-2012) ·initiated 25 Jun 2007

  Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037).

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

Trade Name

Medtronic Interstim Therapy System for Urinary Control

Generic Name

Stimulator, electrical, implantable, for incontinence

PMA Number

P970004 ↗

FDA Product Code

EZW

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, Verify Evaluation System Open recall

  Class III

  FDA PMA P080025 Active Approved 14 Mar 2011

• 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 specific components of the Interstim Therapy System are intended for single-use, and which can be reused across patients?

  The Interstim Therapy System includes single-use components like the implantable pulse generator (IPG) and leads, which are designed for one-time surgical implantation. In contrast, reusable components such as the console programmer and control magnet are intended for use with multiple patients, as they are not implanted and are meant for programming and activation purposes.

• How should the Interstim Therapy System components be stored, and are there any special handling requirements?

  The Interstim Therapy System components must be stored according to the manufacturer’s instructions, though the data does not specify exact storage conditions. Given that it is an implantable device requiring sterile conditions during surgery and handling, it’s critical to follow Medtronic’s guidelines to maintain sterility and functionality. Additionally, the system is MRI-unsafe, so components must be stored away from MRI environments to prevent interference or damage.

• What model numbers are associated with the Interstim Therapy System, and why are they important?

  The Interstim Therapy System includes specific model numbers such as 3886, 3080 (leads), 7424 (IPG), and others listed in the specifications. These model numbers are essential for traceability, regulatory compliance, and ensuring the correct components are used during implantation and programming. They help healthcare providers and manufacturers track the device’s history and verify its suitability for use.

• Is the Interstim Therapy System intended for patients who have not responded to conservative treatments, and how does it work?

  Yes, the Interstim Therapy System is specifically indicated for patients with urinary urge incontinence who have failed or cannot tolerate more conservative treatments. It works by delivering sacral nerve stimulation, which modulates bladder function through electrical impulses delivered by implanted leads connected to an IPG. This targeted neuromodulation helps regulate bladder activity and reduce incontinence symptoms.

• What regulatory pathway was followed for the approval of the Interstim Therapy System, and what classification does it hold?

  The Interstim Therapy System was approved through the FDA’s Premarket Approval (PMA) pathway under PMA number P970004, which is a rigorous process for high-risk devices like implantable stimulators. It is classified under FDA regulation 876.5270 as a Class III device, reflecting its higher risk and the need for extensive clinical validation before approval. This classification ensures the system meets stringent safety and effectiveness standards.