Company: Sorin Biomedica C.R.M
Date of Enforcement Report 9/29//2010
Class ll:

PRODUCT
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Recall # Z-2579-2010

REASON
The Paradym CRT 8750 and CRT sonR 8770 device models have a software anomaly, which will cause the device to lose the ability to sense/pace and to deliver further therapy. The software anomaly could only occur under a specific sequence of events.

RECALLING FIRM/MANUFACTURER
Recalling Firm: ela Medical LLC, Plymouth, MN, by letter dated June 7, 2010.
Manufacturer: Sorin Biomedica C.R.M., S.r.l., Saluggia, VC, Italy. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
215 units

DISTRIBUTION
Nationwide