Events

Retiro De Equipo (Recall) de Device Recall Proclaim Elite SCS IPG

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
    77509
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2691-2017
  • Fecha de inicio del evento
    2017-06-02
  • 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=156177
  • 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
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Causa
    The firm discovered a risk of loss of neuromodulation therapy due to exposure of the ipg to monopolar electrosurgical devices (esu) during medical procedures.
  • Acción
    The notification material is in the form of a Physician Letter and Patient letter which will be delivered to physicians and patients in the US. The physician mailing will be initiated June 2, 2017 for delivery on June 7-9, 2017. The physicians were provided with patient management recommendations, Step for the patient controller updates, and Clinician's Manual Revised Warning. The Patient mailings will begin the week of June 12, 2017 to allow for clinician notification and are expected to be delivered within 3-5 business days. The patient letter informs of them of the potential for the loss of therapy and the steps to receive the software upgrade.

Device

Device Recall Proclaim Elite SCS IPG
  • Modelo / Serial
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO || Product Usage: || The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
  • Manufacturer
    St. Jude Medical, Inc.

Manufacturer

St. Jude Medical, Inc.
  • Dirección del fabricante
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • 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