# P030017: Precision Spinal Cord Stimulation (SCS) System

- Pathway: PMA
- Applicant: Boston Scientific Corp
- Decided: Apr 27, 2004 after 349 days
- Product code: LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief)
- Device class: 3
- Recalls of this device: 17 (1 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
- Jun 17, 2026 · Class I · Z-2879-2026: Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additi
- Apr 29, 2026 · Class II · Z-2404-2026: Sterile anchors my lack sterility assurance.
- Jul 17, 2024 · Class II · Z-2617-2024: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; 
- Apr 24, 2019 · Class II · Z-2121-2020: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the lab
- Apr 24, 2019 · Class II · Z-2120-2020: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the lab
- Apr 24, 2019 · Class II · Z-2124-2020: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the lab
- Apr 24, 2019 · Class II · Z-2119-2020: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the lab
- Apr 24, 2019 · Class II · Z-2122-2020: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the lab
- Apr 24, 2019 · Class II · Z-2123-2020: The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label w
- Mar 19, 2010 · Not classified · Z-1409-2010: Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, th
- Sep 22, 2008 · Not classified · Z-0271-2009: Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the are
- Apr 22, 2008 · Not classified · Z-1441-2012: The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.
- Oct 5, 2007 · Not classified · Z-0960-2008: Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will re
- Aug 3, 2007 · Not classified · Z-0055-2008: Mislabeled: Product labeled with the incorrect shelf-life information.
- Jan 30, 2007 · Not classified · Z-0700-2007: The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.
- Sep 21, 2006 · Not classified · Z-0299-2007: A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the pat
- Nov 11, 2004 · Not classified · Z-0396-05: A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.

Source page: https://510kreport.com/device/P030017
Methodology: https://510kreport.com/methodology