Events

Retiro De Equipo (Recall) de Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por LivaNova Australia Pty Ltd.

¿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
    RC-2017-RN-00493-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00493-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Livanova has identified that in the event of a right ventricular lead issue (e.G. broken or disconnected lead), recurrent shock capacitor charging due to ventricular oversensing may result in depletion of the icd or crt-d battery. because the battery status is not updated for a 24-hour period following a charge, battery depletion may remain undetectable during the 24 hours following the last charge. recurrent charging will stop either after deactivation of the shock therapies, or when the oversensing stops, such as in the case of a lead revision. if an updated battery status is not obtained prior to the lead revision, the need for an icd or crt-d replacement cannot be assessed. if the battery is found to be depleted after the lead revision, adequate therapy may not be available and the patient may have to undergo another surgical procedure to replace the icd or crt-d.
  • Acción
    LivaNova is advising surgeons who have decided to revise the right ventricular lead due to oversensing issues to take the following steps: 1. Prior to lead revision: a) Deactivate the shock therapies to avoid further charging These operations should be performed by medical personnel in an appropriate care unit, with resuscitation equipment present, and after having weighted the benefit/risks for the patient., b) Wait 24 hours1, and c) Re-interrogate the ICD or CRT-D to check the updated battery status. If RRT is reached, initiate a device replacement. Or 2. If it is not possible to wait 24 hours prior to replacing the lead, the lead revision may be performed as scheduled and the device may be replaced prophylactically during the same procedure since the battery status is unknown.

Device

Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardi...
  • Modelo / Serial
    Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Ovatio - CRT 6750, DR 6550, VR 6250Previous ARTG #: 132650, 132586, 132649 Paradym - VR 8250, DR 8550, CRT-D 8750ARTG #: 170105, 170104, 163470,Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770 ARTG #: 197571, 197572, 197573, 197574Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184ARTG #: 230583, 230582, 230580, 230581
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd