Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.

FDA device recall Z-2579-2010 · posted 2010-09-27 · Terminated

Recall details

Recalling firm

ela Medical Llc

Reason for recall

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 occurs under a specific sequence of events.

Action taken

Sorin Group issued a "Medical Device Correction" letter dated June 7, 2010 to consignees. The letter described the product, the problem, and actions to be taken by customers. A Sorin Group representative will contact customers to update the software. Prior to receiving the software update, customers should program the exercise AV delay to 40 ms, which will trigger a reset in the event of an anomaly. This will restore normal operation after shock delivery. If the anolmaly occurs on an implanted unit, a RV coil or SVC coil continuity test should be started, which will ensure that the device recovers proper operation. Corin Group can be contacted at 1-615-788-1807.

Root cause

Software design

Status

Terminated

Product code

NIK

Quantity affected

215

Distribution

Nationwide Distribution in the states of AZ, CA, FL, IA, LA, MA, MS,MO, NJ, NY, NC, OH, OK, PA, SC, TN, TX, and VA.

Date initiated

2010-06-07

Date posted

2010-09-27

Date terminated

2012-03-29

Location

Plymouth, MN