PMA · Approved
Recalled · Class I · 2026Precision Spinal Cord Stimulation (SCS) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Approved on Apr 27, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 349-day review. It has a Class I recall. It has been recalled 17 times, including a Class I recall.
- Decided
- Apr 27, 2004
- Review
- 349 days
- Class
- Class III
- Product code
- LGW
- Recalls
- 17 (1 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030017 has 373 supplements since 2004: 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 |
|---|---|
| 2004 | 2 |
| 2005 | 7 |
| 2006 | 4 |
| 2007 | 11 |
| 2008 | 31 |
| 2009 | 13 |
| 2010 | 25 |
| 2011 | 11 |
| 2012 | 23 |
| 2013 | 33 |
| 2014 | 25 |
| 2015 | 33 |
| 2016 | 26 |
| 2017 | 37 |
| 2018 | 17 |
| 2019 | 10 |
| 2020 | 11 |
| 2021 | 7 |
| 2022 | 4 |
| 2023 | 12 |
| 2024 | 12 |
| 2025 | 8 |
| 2026 | 11 |
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 |
|---|---|---|---|---|
| Jun 17, 2026 | Class I | Z-2879-2026 | Device Design | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead… |
| Apr 29, 2026 | Class II | Z-2404-2026 | Packaging process control | Sterile anchors my lack sterility assurance. |
| Jul 17, 2024 | Class II | Z-2617-2024 | Software design | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired… |
| Apr 24, 2019 | Class II | Z-2121-2020 | Labeling Change Control | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct… |
| Apr 24, 2019 | Class II | Z-2120-2020 | Labeling Change Control | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct… |
| Apr 24, 2019 | Class II | Z-2124-2020 | Labeling Change Control | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct… |
| Apr 24, 2019 | Class II | Z-2119-2020 | Labeling Change Control | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct… |
| Apr 24, 2019 | Class II | Z-2122-2020 | Labeling Change Control | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct… |
| Apr 24, 2019 | Class II | Z-2123-2020 | Labeling Change Control | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by… |
| Mar 19, 2010 | Not classified | Z-1409-2010 | Other | Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in… |
| Sep 22, 2008 | Not classified | Z-0271-2009 | Other | Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1… |
| Apr 22, 2008 | Not classified | Z-1441-2012 | Labeling mix-ups | The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual. |
| Oct 5, 2007 | Not classified | Z-0960-2008 | Device Design | Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0"… |
| Aug 3, 2007 | Not classified | Z-0055-2008 | Error in labeling | Mislabeled: Product labeled with the incorrect shelf-life information. |
| Jan 30, 2007 | Not classified | Z-0700-2007 | Other | The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check. |
| Sep 21, 2006 | Not classified | Z-0299-2007 | Other | A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient. |
| Nov 11, 2004 | Not classified | Z-0396-05 | Other | A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit. |
The 5 latest of 17 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/P030017 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030017: Precision Spinal Cord Stimulation (SCS) System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030017
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026