U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
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.
제품 설명
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. || Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy