FDA WARNING_LETTER - ELA Medical S.A.S. - June 25, 2009

During a June 22-25, 2009, inspection, the FDA found Sorin CRM Business Unit ELA Medical S.A.S., a manufacturer of Ovatio 6750 Implantable Cardioverter Defibrillators (ICDs) in Montrouge, France, in violation of federal regulations. The Ovatio 6750 ICD with CRT and Situs OTW Lead devices were deemed misbranded due to failures in Medical Device Reporting (MDR) as per 21 U.S.C. 352(t)(2) and 21 C.F.R. Part 803.

Key violations include: 1. Failure to report to the FDA within 30 days information suggesting a device caused or contributed to a death or serious injury (21 C.F.R. § 803.50(a)(1)). Examples cited were Complaint No. (b)(4) (May 29, 2008, France) for an Ovatio CRT 6750 failing to deliver shock, and Complaint No. (b)(4) (February 18, 2009, Ohio) for an Ovatio ICD 6550 failing to charge. The firm's response was inadequate regarding adverse events occurring outside the U.S. (OUS) for devices marketed in the U.S. 2