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Sjm™ 3599

by St. Jude Medical, Inc.

Part of a family of 48 devices: see the family page

Ref 3599

Sjm™ 3599 is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 29 Jun 2026 (Basic UDI-DI 5415067SCS0001L4) with CE/MDR certificate MDR 750959 valid until 11 Oct 2027, approved under FDA PMA P010032 on 21 Nov 2001 and listed in FDA GUDID since 29 Jul 2015 (UDI-DI 05415067016553), active as of 23 Oct 2026. 14 FDA recalls are linked to it.

Expiring Expiring in European Union. Active in United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

11 Oct 2027

CE MDR certificate

FDA recalls

8 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

PMA P010032

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067SCS0001L4 Basic UDI-DI 05415067016553UDI-DIDate29 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067016553 UDI-DI Date29 Jul 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP010032 Date21 Nov 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • 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 05415067016553 listed 29 Jul 2015 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 750959 Expiring Supplemented Expires in 333 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    24 Jun 2026
    Expires
    11 Oct 2027
    Reason
    Add device or group

Recalls

14 recalls · 8 ongoing · FDA

    • 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.

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-2511-2023
  2. Recall initiated FDA recalls Z-2509-2023
  3. Recall initiated FDA recalls Z-2510-2023
  4. Recall initiated FDA recalls Z-2507-2023
  5. Recall initiated FDA recalls Z-2505-2023
  6. Recall initiated FDA recalls Z-2506-2023
  7. Recall initiated FDA recalls Z-0458-2026
  8. Certificate issued EUDAMED MDR 750959
  9. Registered EUDAMED 5415067SCS0001L4
  10. Certificate expires EUDAMED MDR 750959

9 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Sjm™
Generic name
Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
Device name
Spinal Cord Stimulation
Model / Ref / Catalog
3599
Primary DI / UDI-DI
05415067016553
Basic UDI-DI
5415067SCS0001L4
PMA number
FDA product code
LGW
EMDN code
Z12101106 Neurological stimulators
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
ImplantableEUDAMED
Yes
GUDID
No

Related devices

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

Cleared under the same submission (P010032)

and 8 more cleared under P010032

Similar devices in this category

Other devices filed under NEUROLOGICAL STIMULATORS.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)