Skip to content

N/A 1210

by Advanced Neuromodulation Systems

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

9 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05415067054111 UDI-DI Date2 Mar 2026ListedStatusListed GUDID: in commercial distribution

Recalls

19 recalls · 9 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0458-2026 FDA Class II initiated 6 Oct 2025
    • Ongoing Z-0459-2026 FDA Class II initiated 6 Oct 2025

    There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

  • 7 recalls, same reason

    • Ongoing Z-2509-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2510-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2507-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2505-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2506-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2508-2023 FDA Class I initiated 18 Jul 2023
    • Ongoing Z-2511-2023 FDA Class I initiated 18 Jul 2023

    Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

  • 6 recalls, same reason

    • Terminated Z-2695-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2696-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2693-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2692-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2694-2017 FDA Class II initiated 2 Jun 2017
    • Terminated Z-2691-2017 FDA Class II initiated 2 Jun 2017

    The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

    • Terminated Z-1785-2013 FDA Class II initiated 30 Nov 2012

    There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the

    • Terminated Z-0025-2013 FDA Class II initiated 4 Sep 2012

    Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.

    • Terminated Z-1738-2013 FDA Class II initiated 26 Jul 2012

    St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica

    • Terminated Z-3091-2011 FDA Unclassified (pre-2012) initiated 2 Jun 2009

    Product programmed with unapproved software was distributed.

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Active implantable device control magnet
Model / Ref / Catalog
1210
Primary DI / UDI-DI
05415067054111
PMA Number
FDA Product Code
LGW, PMP, MHY, NHL, PJS
GMDN Term
Active implantable device control magnet
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (P010032)

Show all (12)

Cleared under the same submission (P140009)

Show all (12)

Cleared under the same submission (P150004)

Show all (12)

Other devices from Advanced Neuromodulation Systems

See all devices from Advanced Neuromodulation Systems →

Properties

  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No