# P110042: Subcutaneous Implantable Defibrillator (S-Icd) System

- Pathway: PMA
- Applicant: Boston Scientific Corporation
- Decided: Sep 28, 2012 after 280 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 11 (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
- Jul 11, 2023 · Class II · Z-2441-2023: There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
- Jul 11, 2023 · Class II · Z-2442-2023: There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
- Sep 30, 2022 · Class II · Z-0152-2023: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
- Sep 30, 2022 · Class II · Z-0151-2023: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
- Nov 1, 2018 · Class II · Z-0474-2019: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
- Jun 29, 2017 · Class II · Z-3037-2017: The device can deliver an atypical amount of energy due to memory corruption inside the device.
- Jun 29, 2017 · Class II · Z-3039-2017: The device can deliver an atypical amount of energy due to memory corruption inside the device.
- Jun 29, 2017 · Class II · Z-3038-2017: The device can deliver an atypical amount of energy due to memory corruption inside the device.
- Jan 12, 2017 · Class II · Z-1178-2017: There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior
- Sep 17, 2015 · Class II · Z-0232-2016: Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of succe
- Mar 1, 2013 · Class II · Z-0965-2013: An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deli

Source page: https://510kreport.com/device/P110042
Methodology: https://510kreport.com/methodology