Device product

ORCHESTRA/ORCHESTRA PLUS Programmer

Z-0805-2014

November 20, 2013

Class II

Product summary

Firm: Sorin Group Italia S.r.l.
Event: Event 67013
Status: Terminated
Classification: Class II
Quantity: 1,718
Official record key: device-enforcement:Z-0805-2014

Official wording

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.

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

Distribution pattern: Nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.