Events

Retiro De Equipo (Recall) de Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sorin Group Italia S.r.l..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67013
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0805-2014
  • Fecha de inicio del evento
    2013-11-20
  • Fecha de publicación del evento
    2014-01-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124518
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Computers and software - Product Code LNX
  • Causa
    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.
  • Acción
    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
  • Modelo / 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
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide.
  • Descripción del producto
    ORCHESTRA/ORCHESTRA PLUS Programmer
  • Manufacturer
    Sorin Group Italia S.r.l.

Manufacturer

Sorin Group Italia S.r.l.
  • Dirección del fabricante
    Sorin Group Italia S.r.l., Via Crescentino, Saluggia, VC Italy
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA