3042

• EUDAMED Basic UDI-DI 5415067SCS0001L4 registered 29 Jun 2026 Active· +1 more in the status table
• FDA PMA P010032 decided 21 Nov 2001 Active
• FDA GUDID UDI-DI 05415067051882 listed 9 Apr 2025 Listed

• • Ongoing Z-0458-2026 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-2508-2023 FDA Class I ·initiated 18 Jul 2023
  • Ongoing Z-2511-2023 FDA Class I ·initiated 18 Jul 2023
  • 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

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

• 2 recalls, same reason

  • Terminated Z-2692-2017 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.

1. 18 Jul 2023 Recall initiated FDA recalls Z-2509-2023
2. 18 Jul 2023 Recall initiated FDA recalls Z-2510-2023
3. 18 Jul 2023 Recall initiated FDA recalls Z-2507-2023
4. 18 Jul 2023 Recall initiated FDA recalls Z-2505-2023
5. 18 Jul 2023 Recall initiated FDA recalls Z-2506-2023
6. 9 Apr 2025 Listed FDA GUDID 05415067051882
7. 6 Oct 2025 Recall initiated FDA recalls Z-0458-2026
8. 24 Jun 2026 Certificate issued EUDAMED MDR 750959
9. 29 Jun 2026 Registered EUDAMED 5415067SCS0001L4
10. 11 Oct 2027 Certificate expires EUDAMED MDR 750959

9 earlier events are in the sections above.

Generic name

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

Device name

Spinal Cord Stimulation

Model / Ref / Catalog

3042

Primary DI / UDI-DI

05415067051882

Basic UDI-DI

5415067SCS0001L4

PMA number

P010032 ↗

FDA product code

LGW

EMDN code

Z12101185 Peripheral or central neuro stimulation and assessment instruments - consumables

GMDN term

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

Device class

Class III

EU registration type

Standard device

EU market of registration

Belgium

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

Category: Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

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  FDA PMA ×3 Active Approved 21 Nov 2001 GUDID on market

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See all devices from Advanced Neuromodulation Systems →