User's Manual

14 – US-ENGLISH
Never incinerate the device due to the potential for explosion.
The device must be explanted before cremation.
5. ADVERSE EVENTS
Clinical data presented in this section are from the MSP clinical
study. PARADYM RF SonR CRT-D is similar in design and function
to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided
are applicable to PARADYM RF SonR CRT-D.
5.1. MSP STUDY
Sorin CRM conducted an international, multi-center, randomized
clinical trial of its cardiac resynchronization therapy system.
Investigators attempted to implant study devices in 190 patients. A total
of 182 patients received study devices and had an exposure of over
165 device years. Of those patients, 19 received OVATIO CRT-D, 160
received ALTO 2 MSP, and 3 received ALTO MSP. The clinical data
collected on ALTO MSP, ALTO 2 MSP and OVATIO CRT-D are
applicable to PARADYM RF SonR CRT-D. The table below
summarizes the adverse events observed for the CRT-D system. No
deaths were related to the system.