# P840001: Itrel (R) Totally Implantable Spinal Cord Stim. Sys

- Pathway: PMA
- Applicant: Medtronic Neuromodulation
- Decided: Nov 30, 1984 after 322 days
- Product code: LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief)
- Device class: 3
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Sep 18, 2024 · Class II · Z-0372-2025: 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: inability to reprogram one device
- Dec 19, 2023 · Class II · Z-0780-2024: 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 
- Jul 9, 2021 · Class II · Z-2159-2021: 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: 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 r
- Jan 9, 2015 · Class II · Z-1147-2015: 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
- Feb 27, 2014 · Class II · Z-1524-2014: 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 set
- Sep 30, 2013 · Class II · Z-0278-2014: Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creatin
- Aug 2, 2006 · Not classified · Z-1536-06: 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 co

Source page: https://510kreport.com/device/P840001
Methodology: https://510kreport.com/methodology