BEUDAMED
    FDA Recall Terminated

    ORCHESTRA/ORCHESTRA PLUS Programmer

    Recall: Z-0805-2014 · Initiated November 20, 2013

    Recall

    Recall Number
    Z-0805-2014
    Event Number
    67013
    Firm
    Sorin Group Italia S.r.l. Via Crescentino Saluggia, VC Italy
    FEI Number
    1000165971
    Product Code
    LNX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 20, 2013
    Posted
    January 22, 2014
    Terminated
    September 8, 2014

    Description

    ORCHESTRA/ORCHESTRA PLUS Programmer

    Reason

    Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.

    Action

    On Nov 20 and Nov 25, 2013, the Dear Doctor Letter was sent by certified mail to 1,310 physicians who are following 13,003 patients implanted with a REPLU or ESPRIT pacemakers in the US. Sorin provided the following recommendations to the physicians: You should consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit. When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre. As a general rule, a maximum of 6 month follow-up interval when the battery impedance becomes greater than or equal to 3.5 k. This recommendation should also be followed subsequent to the installation of the new programmer software version.

    Distribution

    Nationwide.

    Quantity

    1,718