Events

Retiro De Equipo (Recall) de Quadra Assura MP

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
    80212
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2325-2018
  • Fecha de inicio del evento
    2018-04-16
  • 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=164889
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
  • Causa
    The firm is releasing new firmware for high voltage implantable cardiac devices (icd) and cardiac resynchronization therapy defibrillators (crt-d) intended to strengthen security by providing an additional layer of protection against unauthorized device access. for older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the rf communication capability in these devices.
  • Acción
    On 04/16/2018, Important Medical Device Advisory notifications were mailed via overnight service to U.S. physicians and hospitals notifying customers of the availability of the programmer software update and associated ICD/CRT-D firmware update. Advisory notifications were mailed to customers outside the U.S. on different dates depending on geography and local regulatory requirements. Prophylactic replacement of affected devices is not recommended. The firm recommends firmware upgrades for all eligible patients at the next regularly scheduled visit or when appropriate depending on the preferences of the patient and physician. For devices not eligible for the cybersecurity firmware update the firm recommends a discussion of the risks of cybersecurity vulnerabilities and proven benefits of remote monitoring with patients at their next regularly scheduled visit. RF communication may be permanently disabled in devices not eligible for firmware updates during an in-clinic device interrogation with a programmer that has received the software update. Customers with questions about the firmware update can call the customer technical support hotline at 1-800-436-5056.

Device

Quadra Assura MP
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    U.S. Nationwide distribution
  • Descripción del producto
    Quadra Assura MP, Sterile EO, Model #/ Part #: || CD3269-40/100043177; || CD3269-40Q/100043178; || CD3271-40/100043130; || CD3271-40Q/100043191; || CD3369-40C/100080339, 100080478; || CD3369-40Q/100080439, 100080476, 100105528; || CD3371-40/100078814, 100079232, 100079513; || CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; || CD3371-40Q/100078815,100079282, 100079479, 100138237; || CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; || CD3387-40C/100105525; || CD3387-40QC/100138158
  • 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