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U.S. Department of Health and Human Services

Class 2 Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer

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 Class 2 Recall
ORCHESTRA/ORCHESTRA PLUS Programmer
see related information
Date Posted January 22, 2014
Recall Status1 Terminated on September 08, 2014
Recall Number Z-0805-2014
Recall Event ID 67013
Premarket Approval
PMA Numbers
P060027/S011 P060027/S032 P950029/S041 P980049/S050 P980049/S065
Product Classification Medical Computers And Software - Product Code LNX
Product ORCHESTRA/ORCHESTRA PLUS Programmer
Code Information ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1
Recalling Firm/
Manufacturer
Sorin Group Italia S.r.l.
Via Crescentino
Saluggia, VC
For Additional Information Contact Steve Smith
303-467-6222
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Quantity in Commerce 1,718
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LNX and Applicant = ELA MEDICAL, INC.
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