Events

Retiro De Equipo (Recall) de Device Recall Platinium VR 1210

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 SRL - CRF.

¿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
    77983
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3228-2017
  • Fecha de inicio del evento
    2017-07-24
  • Fecha de publicación del evento
    2017-09-28
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158438
  • 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
    Defibrillator, implantable, dual-chamber - Product Code MRM
  • Causa
    There is a possibility of overconsumption of certain platinium implantable cardiac defibrillators (icds) and cardiac resynchronization therapy defibrillators (crt-ds) following an electrostatic discharge (esd) during the implant surgery or a magnetic resonance imaging (mri) scan, and what actions to take.
  • Acción
    LivaNova issued a communication to physicians treating patients implanted with the products in scope in the form of a customer letter beginning July 24, 2017. The letter instructs users to do the following: 1. In order to mitigate the potential risks associated with both triggering events (ESD at implant or MRI scan), LivaNova recommends physicians follow the patients at the periodicity already stated in the implant manual, especially: " Before the patient is discharged and at each subsequent follow-up, it is advisable to check the battery status and the occurrence of system warnings; " It is recommended that a routine follow-up examination be done one month after discharge, and then every three months until the device nears the replacement date.

Device

Device Recall Platinium VR 1210
  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, || Biventricular or ventricular antitachycardia pacing, || Dual or single chamber arrhythmia detection || Product Usage: || PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
  • Manufacturer
    Sorin Group Italia SRL - CRF

Manufacturer

Sorin Group Italia SRL - CRF
  • Dirección del fabricante
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA