Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer 의 리콜

Recall

67013

Class 2

Z-0805-2014

2013-11-20

2014-01-22

Terminated

United States

2014-09-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124518

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.