PMA · Approved
Recalled · Class II · 2024Itrel (R) Totally Implantable Spinal Cord Stim. Sys
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neuromodulation · LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Approved on Nov 30, 1984 through premarket approval, which rests on the device’s own clinical evidence after a 322-day review. It has been recalled 9 times.
- Decided
- Nov 30, 1984
- Review
- 322 days
- Class
- Class III
- Product code
- LGW
- Recalls
- 9
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P840001 has 612 supplements since 1985: 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 |
|---|---|
| 1985 | 4 |
| 1986 | 4 |
| 1987 | 3 |
| 1988 | 3 |
| 1989 | 3 |
| 1990 | 4 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 7 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 4 |
| 2001 | 9 |
| 2002 | 7 |
| 2003 | 4 |
| 2004 | 3 |
| 2005 | 8 |
| 2006 | 8 |
| 2007 | 5 |
| 2008 | 19 |
| 2009 | 20 |
| 2010 | 28 |
| 2011 | 29 |
| 2012 | 29 |
| 2013 | 27 |
| 2014 | 28 |
| 2015 | 30 |
| 2016 | 32 |
| 2017 | 36 |
| 2018 | 31 |
| 2019 | 34 |
| 2020 | 26 |
| 2021 | 23 |
| 2022 | 30 |
| 2023 | 24 |
| 2024 | 28 |
| 2025 | 29 |
| 2026 | 20 |
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.
Planning a device in LGW? 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? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2024 | Class II | Z-0372-2025 | Under Investigation by firm | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. |
| Mar 28, 2024 | Class II | Z-1691-2024 | Under Investigation by firm | inability to reprogram one device |
| Dec 19, 2023 | Class II | Z-0780-2024 | Under Investigation by firm | Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to… |
| Jul 9, 2021 | Class II | Z-2159-2021 | Error in labeling | Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling. |
| May 3, 2016 | Class II | Z-1926-2016 | Under Investigation by firm | Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925… |
| Jan 9, 2015 | Class II | Z-1147-2015 | Other | Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate… |
| Feb 27, 2014 | Class II | Z-1524-2014 | Labeling False and Misleading | Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is… |
| Sep 30, 2013 | Class II | Z-0278-2014 | Software design | Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be… |
| Aug 2, 2006 | Not classified | Z-1536-06 | Other | Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled… |
The 5 latest of 9 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/P840001 · printed Nov 6, 2026
Cite this page
510(k) Report. “P840001: Itrel (R) Totally Implantable Spinal Cord Stim. Sys.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P840001
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026