Events

Notificaciones De Seguridad De Campo acerca de Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por LivaNova PLC.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-07-24
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Notas adicionales en la data
  • Causa
    1. an electronic component used in a specific hardware version of platinium devices has been found to be sensitive to electrostatic discharge (esd) potentially generated during the implant surgery. the discharge can trigger overconsumption of current, leading to reduced device longevity (5% longevity loss per month). the overconsumption is detectable upon interrogation of the device during follow-up visit and it can be stopped by resetting the device. although the overconsumption is stopped after this reset, the residual longevity displayed by the programmer may temporarily be underestimated. 2. although platinium devices are not currently approved as mri conditional and are therefore contraindicated for mri, livanova is aware that some patients implantedwith a platinium device have undergone an mri scan based upon medical judgment weighing the benefits and risks of the procedure. when exposure to an mri’s magnetic field occurs, overconsumption can occur and the battery voltage will decrease to 2.80v. at this level, the device remaining longevity is 25% of the initial longevity. neither of the issues described above affect the therapeutic functions of the device. all sensing, pacing and shock delivery capabilities will remain functional. .

Device

Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibri...

Manufacturer

LivaNova PLC