Skip to content

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

by Medtronic Neuromodulation

PMA P840001

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

PMA P840001↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP840001 Date30 Nov 1984ApprovedStatusActive

Recalls

9 recalls · 4 ongoing · FDA

    • Ongoing Z-0372-2025 FDA Class II initiated 18 Sep 2024

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

    • Ongoing Z-1691-2024 FDA Class II initiated 28 Mar 2024

    inability to reprogram one device

    • Ongoing Z-0780-2024 FDA Class II initiated 19 Dec 2023

    Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.

    • Ongoing Z-2159-2021 FDA Class II initiated 9 Jul 2021

    Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.

    • Terminated Z-1926-2016 FDA Class II initiated 3 May 2016

    Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.

    • Terminated Z-1147-2015 FDA Class II initiated 9 Jan 2015

    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-1524-2014 FDA Class II initiated 27 Feb 2014

    Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval

    • Terminated Z-0278-2014 FDA Class II initiated 30 Sep 2013

    Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).

    • Terminated Z-1536-06 FDA Unclassified (pre-2012) initiated 2 Aug 2006

    Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade Name
Itrel(R) Totally Implantable Spinal Cord Stim. Sys
Generic Name
Stimulator, spinal-cord, totally implanted for pain relief
PMA Number
FDA Product Code
LGW
Device Class
Class III
Advisory Committee
Neurology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems, along with the Pisces, Specify, and Vectris Spinal Cord Stimulation Leads, are totally implanted spinal-cord stimulators designed for pain relief. These devices deliver electrical impulses to the spinal cord to modulate pain signals, providing therapeutic intervention for chronic pain conditions.

These systems are intended for surgical implantation by trained medical professionals and are supplied as reusable components, including the stimulator and leads. The devices are classified as Class III under FDA regulations and have received FDA_PMA authorization. Storage and handling follow sterile medical device protocols, with specific models and reference codes listed for identification and regulatory tracking.

Other devices from Medtronic Neuromodulation

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of chronic pain conditions are these spinal cord stimulation systems designed to address?

    These systems—Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems—are intended for pain relief via electrical modulation of spinal cord signals. While the exact conditions aren’t specified, they are typically used for chronic pain syndromes where traditional therapies fail, such as neuropathic pain, failed back surgery syndrome, or complex regional pain syndrome. The devices are not intended for acute pain or non-pain indications.

  • Are the stimulator components reusable, and if so, how should they be handled to maintain sterility?

    Yes, the stimulator and lead components are designed for reusable surgical use after proper sterilization. Since they are implanted, they must adhere to sterile medical device protocols during handling, storage, and reprocessing. The manufacturer’s instructions (not detailed here) should specify cleaning, disinfection, and sterilization methods to ensure safety and functionality before reuse.

  • What is the regulatory pathway for these devices, and how can I verify their authorization status?

    These systems are Class III devices under FDA regulations and have received PMA (Premarket Approval) authorization via PMA number P840001. Their regulatory status can be verified through the FDA’s OpenFDA API using the provided FEI numbers (e.g., 3007616088) or via the FDA’s device database. The product code LGW also categorizes them for tracking. No CE marking or other non-FDA approvals are mentioned.

  • How do I identify the correct model or reference code for ordering these devices?

    Each system (Itrel, Synergy, Intellis) and lead (Pisces, Specify, Vectris) has unique reference codes listed in the FEI numbers (e.g., 3007616088) and registration numbers (e.g., 3004593495). These codes are used for regulatory tracking, inventory, and ordering. For precise identification, consult the manufacturer’s catalog or contact Medtronic Neuromodulation directly, as the exact model specifications (e.g., electrode configurations, battery life) vary by code.