Events

Alerta De Seguridad O Notificaciones De Seguridad para GEM® DR and Micro Jewel® II ICDs

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/2004/045
  • Número del evento
    CON008505
  • Fecha
    2004-09-09
  • 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/CON008505
  • 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
    Extended charge times and inability to deliver therapy at battery voltages close to elective replacement indicator (eri) for a subset of the above devices. since 1999 medtronic has issued a series of advisory notices concerning the performance of some gem® dr and micro jewel® ii icds. medtronic's most recent advisory notice is appended to this alert and updates previous follow-up recommendations for affected gem® dr and micro jewel® ii icds. this most recent advisory notice followed receipt of reports in which appropriate therapy had not been delivered during cardiac arrhythmias. medtronic was concerned that these devices may not be capable of delivering adequate high voltage defibrillation therapy at or near the specified eri at 4.91v, or during the following period to end of life (eol), specified at 4.57v. the mhra is publishing this medical device alert to reiterate the recommendations made by medtronic, and to update and replace advice previously issued by the medical devices agency in ptn no. 80.
  • Acción
    Note that the recommendations in this update supersede the advice given in Pacemaker Technical Note (PTN No. 80 issued by the Medical Devices Agency in October 1999. Identify patients affected by referring to the serial numbers listed in Appendix 2. Follow the detailed instructions given in Medtronic's Advisory Notice (see Appendix 1). Carry out the following actions for all affected patients (refer to list of serial numbers): battery voltage of 5.16V or less , charge time of 18 seconds or greater . Trust managers should ensure that measures to implement the actions specified above are planned and completed within the following SABS deadlines: ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

GEM® DR and Micro Jewel® II ICDs
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Descripción del producto
    Medtronic implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx. Medtronic GEM® DR and Micro Jewel® II ICDs manufactured with suspect capacitors and having serial numbers as indicated in Appendix 2.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429