Events

Retiro De Equipo (Recall) de Device Recall Accent family of pacemakers

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por St Jude Medical Inc..

¿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
    78093
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0035-2018
  • Fecha de inicio del evento
    2017-08-28
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158779
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable pulse generator, pacemaker (non-CRT) - Product Code LWP
  • Causa
    New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (rf) communications.
  • Acción
    Abbott sent an Important Cybersecurity Advisory dated August 28, 2017, to all affected customers to notify customers of the availability of the programmer software update and associated pacemaker firmware update. The notification material is in the form of a Physician Letter and Hospital Letter and will be delivered to physicians and hospitals with inventory in the US by overnight service. Customers with questions were instructed to contact their Abbott representative or the customers technical support hotline at 1-800-722-3774.

Device

Device Recall Accent family of pacemakers
  • Modelo / Serial
    Serial Numbers: 2736872 2736871 2736870 2736874 2736873 2538305 2538304 2538301 2538306 2538307 2538302 2512808 2512812 2512811 2384089 2512807 2384108 2384112 2397881 2393253 2393254 2401631 2512803 2401623 2401617 2512810 2384086 2384126 2384101 2384122 2384121 2384105 2384096 2384098 2384116 2384110 2384111 2384120 2384082 2384085 2384123 2384124 2384107 2384117 2384087 2384097 2384077 2393264 2384115 2384119 2384114 2384104 2384100 2384078 2384092 2384081 2384084 2397878 2401620 2384080 2384079 2384099 2401621 2401624 2384083 2512819 2512818 2401626 2401622 2397879 2397872 2393252 2393259 2401619 2401618 2401629 2397874 2397880 2401628 2384106 2393255 2393256 2393257 2512802 2512805 2512800 2512817 2512801 2512804 2512813 2512814 2512815 2512816 2512806 2512809 2384102 2384095 2384125 2384113 2384103 2393262
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST || These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
  • Manufacturer
    St Jude Medical Inc.

Manufacturer

St Jude Medical Inc.
  • Dirección del fabricante
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA