# P010032: Genesis and Eon Family Neurostimulation (Ipg) Systems

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Nov 21, 2001 after 176 days
- Product code: LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief)
- Device class: 3
- Recalls of this device: 14 (7 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.
1 of 1 device in its family (counting itself) has 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
- Oct 6, 2025 · Class II · Z-0458-2026: 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 (IPG
- Jul 18, 2023 · Class I · Z-2506-2023: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 wou
- Sep 4, 2012 · Class II · Z-0025-2013: 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,
- Jul 26, 2012 · Class II · Z-1738-2013: 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 Syste
- Jun 2, 2009 · Not classified · Z-3091-2011: Product programmed with unapproved software was distributed.

Source page: https://510kreport.com/device/P010032
Methodology: https://510kreport.com/methodology