ORCHESTRA/ORCHESTRA PLUS Programmer

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.

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.