BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2579-2010 · Initiated June 7, 2010

    Recall

    Recall Number
    Z-2579-2010
    Event Number
    56199
    Firm
    ela Medical Llc
    FEI Number
    2182863
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 7, 2010
    Posted
    September 27, 2010
    Terminated
    March 29, 2012
    Address
    2905 Northwest Blvd, Ste 40, Plymouth, MN, 55441-2673

    Description

    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

    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 occurs under a specific sequence of events.

    Action

    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.

    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.

    Quantity

    215