Alerta De Seguridad O Notificaciones De Seguridad para Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Contak Renewal

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
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Recall due to component failure resulting in potential loss of cardioversion, defibrillation and reduced device longevity. guidant has informed mhra that all serial numbers of contak renewal® 4, contak renewal® 4 avt and renewal® rf devices are subject to a component failure that could result in limited available therapy, inappropriate therapy and a reduction in device longevity. as a precautionary measure, guidant has advised clinicians not to implant affected devices until further notice. guidant has confirmed that the magnetic switch in these devices has the potential to stick in the closed position, resulting in the inhibition of the device's ability to treat ventricular or atrial tachyarrhythmias. bradycardia pacing remains unaffected. an audible tone, emitted from the device warns patients and/or clinicians of this condition. this component failure will increase the device's battery consumption and significantly reduce device longevity. to date, guidant has distributed approximately 46,000 of these devices worldwide. there have been five reports, four confirmed and one unconfirmed, of component failure. the four incidents resulted in device replacement. in the uk, 670 devices have been distributed. there have been no reports of this component failure in the uk. the default setting for these devices is 'enable magnet use on'. for devices already implanted, guidant recommends reprogramming the device to 'enable magnet use off'. in 'enable magnet use off' mode: bradycardia pacing and treatment of tachyarrhythmias will continue as programmed if the magnetic switch becomes stuck in the closed position a magnet will no longer inhibit therapy temporary suspension of tachyarrhythmia therapy can be performed with a programmer the time between elective replacement indicators (eri) and end-of-life (eol) may be shortened.
  • Acción
    See actions on page 2. Do not implant these devices until further notice from Guidant. Immediately segregate all unimplanted devices and return them to Guidant in accordance with their instructions. Review patients already implanted with these devices and verify device function using normal follow-up procedures. Instruct patients to go to a hospital Accident and Emergency department immediately or to contact their clinician if they hear bleep tones from their device. Consider programming device to 'Enable Magnet Use OFF'. Ensure that follow-up intervals are no greater than three months (as per instructions for use). Consider prophylactic explantation if the proposed programming option does not meet patient needs. 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:


  • Modelo / Serial
  • Descripción del producto
    Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) Device Family Model Numbers CONTAK RENEWAL© 4  H190, H195  CONTAK RENEWAL© 4 HE  H197, H199  CONTAK RENEWAL© 4 AVT  M170, M175  CONTAK RENEWAL© 4 AVT HE  M177, M179  RENEWAL© RF  H230, H235  RENEWAL© RF HE  H239
  • Manufacturer