# P080025: Medtronic Interstim Sacral Nerve Stimulation Therapy System

- Pathway: PMA
- Applicant: Medtronic Neuromodulation
- Decided: Mar 14, 2011 after 899 days
- Product code: QON (Implanted Electrical Device Intended For Treatment Of Fecal Incontinence)
- Device class: 3
- Regulation: 21 CFR 876.5270
- Recalls of this device: 5 (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
- Apr 3, 2025 · Class II · Z-1704-2025: Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop 
- 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.
- Jul 6, 2023 · Class II · Z-2365-2023: Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
- Feb 28, 2022 · Class II · Z-0998-2022: There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being 
- 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

Source page: https://510kreport.com/device/P080025
Methodology: https://510kreport.com/methodology