| Class 2 Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer | |
Date Initiated by Firm | November 20, 2013 |
Date Posted | January 22, 2014 |
Recall Status1 |
Terminated 3 on September 08, 2014 |
Recall Number | Z-0805-2014 |
Recall Event ID |
67013 |
PMA Number | P950029S041 P980049S050 P060027S011 P980049S006 |
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 Italy
|
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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