# P970004: Medtronic Interstim Therapy System for Urinary Control

- Pathway: PMA
- Applicant: Medtronic Neuromodulation
- Decided: Sep 29, 1997 after 242 days
- Product code: EZW (Stimulator, Electrical, Implantable, For 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K013063: Grip Lock Anchor, Model 411374 (2001), 0 descendants of its own

## 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.
- 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
- Jun 25, 2007 · Not classified · Z-0040-2008: Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an
- Jun 25, 2007 · Not classified · Z-0037-2008: A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) be

Source page: https://510kreport.com/device/P970004
Methodology: https://510kreport.com/methodology