Events

Alerta De Seguridad O Notificaciones De Seguridad para Guidant VENTAK PRIZM® 2 DR

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por manufacturer #17429.

¿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
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2005/037
  • Número del evento
    CON1004068
  • Fecha
    2005-06-27
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON1004068
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Potential loss of cardioversion, defibrillation or pacing therapy due to diversion of high voltage shock. following reports of malfunction from clinicians outside the uk, guidant reviewed the design and manufacturing processes for the ventak prizm® 2 dr icd. the company identified the potential for loss of therapy in all units manufactured on or before 16 april 2002, when corrective measures were implemented. on delivery of defibrillation therapy, the high voltage pulse may discharge (or arc) between the high voltage defibrillation output wire and a header component. the resulting discharge current may damage the icd electronics and cause any of the following: loss of: arrhythmia detection / therapy delivery bradycardia pacing output telemetry/ programming/ interrogation a red warning screen indicating malfunction a yellow warning screen indicating 'out of range' shocking impedance.
  • Acción
    See action points on page 3. Ensure that follow-up intervals are no greater than three months; consider immediate review of all patients whose last follow-up was more than three months ago. Replace all devices in which high voltage therapy has been compromised. Remind patients to contact their follow-up centre immediately, if they hear audible bleeping from their device, experience shock therapy and/or arrhythmias/resumption of symptoms which remain uncorrected by the device. Report all instances of device failure to MHRA and Guidant Report explants to the National Pacing and ICD database (see contacts). ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Trust managers should ensure that measures to implement the 'Actions' specified above are planned and completed in line with the following SABS deadlines. Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

Guidant VENTAK PRIZM® 2 DR
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Guidant VENTAK PRIZM® 2 DR implantable cardioverter defibrillator (ICD) model No 1861 - see Appendix for full list of affected serial numbers.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429