PMA · Approved
Recalled · Class I · 2025Genesis and Eon Family Neurostimulation (Ipg) Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Approved on Nov 21, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 176-day review. It has a Class I recall. It has been recalled 14 times, including 7 Class I recalls.
- Decided
- Nov 21, 2001
- Review
- 176 days
- Class
- Class III
- Product code
- LGW
- Recalls
- 14 (7 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P010032 has 244 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 5 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 5 |
| 2010 | 3 |
| 2011 | 7 |
| 2012 | 16 |
| 2013 | 11 |
| 2014 | 15 |
| 2015 | 18 |
| 2016 | 17 |
| 2017 | 11 |
| 2018 | 8 |
| 2019 | 10 |
| 2020 | 10 |
| 2021 | 17 |
| 2022 | 7 |
| 2023 | 16 |
| 2024 | 22 |
| 2025 | 15 |
| 2026 | 14 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2025 | Class II | Z-0458-2026 | Process control | 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… |
| Jul 18, 2023 | Class I | Z-2506-2023 | Under Investigation by firm | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Jul 18, 2023 | Class I | Z-2505-2023 | Under Investigation by firm | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Jul 18, 2023 | Class I | Z-2511-2023 | Under Investigation by firm | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Jul 18, 2023 | Class I | Z-2508-2023 | Under Investigation by firm | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Jul 18, 2023 | Class I | Z-2510-2023 | Under Investigation by firm | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Jul 18, 2023 | Class I | Z-2509-2023 | Under Investigation by firm | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Jul 18, 2023 | Class I | Z-2507-2023 | Under Investigation by firm | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). |
| Jun 2, 2017 | Class II | Z-2692-2017 | Device Design | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. |
| Jun 2, 2017 | Class II | Z-2691-2017 | Device Design | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. |
| Nov 30, 2012 | Class II | Z-1785-2013 | Device Design | 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… |
| Sep 4, 2012 | Class II | Z-0025-2013 | Nonconforming Material/Component | 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… |
| Jul 26, 2012 | Class II | Z-1738-2013 | Device Design | 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… |
| Jun 2, 2009 | Not classified | Z-3091-2011 | Software change control | Product programmed with unapproved software was distributed. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LGW devicesLGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LGW
65in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGW
Too few LGW 510(k)s in any year since 2007 to give a median.
Recalls per year · LGW
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LGW
31,054in 2025
MAUDE reports naming product code LGW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | — | 4 | 1,094 |
| 2008 | 53 | — | 4 | 3,018 |
| 2009 | 38 | — | 2 | 5,251 |
| 2010 | 56 | — | 2 | 9,265 |
| 2011 | 47 | — | 1 | 11,132 |
| 2012 | 68 | — | 1 | 17,915 |
| 2013 | 71 | — | 3 | 22,432 |
| 2014 | 68 | — | 0 | 11,250 |
| 2015 | 72 | — | 0 | 11,690 |
| 2016 | 92 | — | 2 | 15,643 |
| 2017 | 94 | — | 2 | 18,612 |
| 2018 | 64 | — | 0 | 23,626 |
| 2019 | 69 | — | 0 | 30,038 |
| 2020 | 52 | — | 1 | 28,106 |
| 2021 | 56 | — | 1 | 24,333 |
| 2022 | 60 | — | 5 | 23,269 |
| 2023 | 63 | — | 2 | 33,528 |
| 2024 | 94 | — | 2 | 35,074 |
| 2025 | 65 | — | 3 | 31,054 |
| 2026 | 56 | — | 2 (1) | — |
https://510kreport.com/device/P010032 · printed Nov 6, 2026
Cite this page
510(k) Report. “P010032: Genesis and Eon Family Neurostimulation (Ipg) Systems.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P010032
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026