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Advanced Neuromodulation Systems

Last updated May 23, 2026

Information

Country: US
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Catalogue (69)

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Device	Model / Reference	Registries	Class	Status
Placer	K032349	FDA 510(k)	Class II	Active
Lamitrode S-Series (s4 And S8) Leads	K022222	FDA 510(k)	Class II	Active
Tripole 8c And 16c And Exclaim 8 Lamitrode Series Leads	K063080	FDA 510(k)	Class II	Active
Swift-Lock Anchor, Model 1192	K092371	FDA 510(k)	Class II	Active
Trial Cable Retention Clip	K050633	FDA 510(k)	Class II	Active
Mts Multiprogram Trial Stimulator System	K033757	FDA 510(k)	Class II	Active
Renew Lead Extension	K991784	FDA 510(k)	Class II	Active
Lamitrode Spinal Cord Stimulation Leads	K033429	FDA 510(k)	Class II	Active
Cinch Anchor, Model 1194	K081208	FDA 510(k)	Class II	Active
Modification To Renew Lead Extension	K032751	FDA 510(k)	Class II	Active
Penta Lead Kits, Models: 3227-3234	K090907	FDA 510(k)	Class II	Active
Trial Cable, 3009	K070847	FDA 510(k)	Class II	Active
Rapid Programmar	K030118	FDA 510(k)	Class II	Active
Ans 90 Cm And 110 Cm (3100 And 3200 Series) Lead Kit	K053250	FDA 510(k)	Class II	Active
Modification To Axxess Spinal Cord Stimulation Lead	K030674	FDA 510(k)	Class II	Active
Paindoc	K021518	FDA 510(k)	Class II	Active
Renew Neurostimulation System	K000852	FDA 510(k)	Class II	Active
Lamitrode Leads	K990469	FDA 510(k)	Class II	Active
Ans Axxess Percutaneous Lead	K032034	FDA 510(k)	Class II	Active

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 4, 2012	Z-0025-2013	—	terminated	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.
Mar 28, 2012	Z-0894-2013	—	terminated	Unintended Fluid ingress into the device header has been shown.
Dec 19, 2011	Z-2280-2012	—	terminated	As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
Dec 19, 2011	Z-1983-2012	—	terminated	The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin
Dec 19, 2011	Z-2281-2012	—	terminated	As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
May 24, 2011	Z-2607-2011	—	terminated	Defective battery was identified as cause for reports of inability to communicate or recharge the product.
Apr 23, 2010	Z-1599-2010	—	terminated	Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
Feb 22, 2010	Z-1425-2010	—	terminated	Directions For Use of product incorrectly stated lead compatibility information.
Jun 2, 2009	Z-3091-2011	—	terminated	Product programmed with unapproved software was distributed.
Dec 22, 2006	Z-0170-2010	—	terminated	Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system.