Events

Recall of Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group Italia S.r.l..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67013
  • Event Risk Class
    Class 2
  • Event Number
    Z-0805-2014
  • Event Initiated Date
    2013-11-20
  • Event Date Posted
    2014-01-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124518
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Medical Computers and software - Product Code LNX
  • 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.
  • 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.

Device

Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    ORCHESTRA/ORCHESTRA PLUS Programmer
  • Manufacturer
    Sorin Group Italia S.r.l.

Manufacturer

Sorin Group Italia S.r.l.
  • Manufacturer Address
    Sorin Group Italia S.r.l., Via Crescentino, Saluggia, VC Italy
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA