Events

Retiro De Equipo (Recall) de Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer,

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 Nuvectra.

¿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
    73884
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1600-2016
  • Fecha de inicio del evento
    2016-04-06
  • Fecha de publicación del evento
    2016-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-09-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145307
  • 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
    If used, the optional swap feature copies programming parameters from the external pulse generator (epg) as well as unintended calibration data to the implantable pulse generator (lpg). this may result in the user being unable to recharge the lpg. this safety notice only applies to cps model 4500.
  • Acción
    Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 2016 to customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken.

Device

Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer,
  • Modelo / Serial
    Serial 000010 000011 FF0043 FF0045 000014 000015 000016 FF0054 FF0048 FF004B FF005D FF0064 FF0065 FF0067 FF00A9 FF00AD FF00BB   Lot  P178713 P185700 P187989 P195875 P213108 P257056
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Germany
  • Descripción del producto
    Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. || The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient¿¿"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient¿¿"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient¿¿"s use of the system. || The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs
  • Manufacturer
    Nuvectra

Manufacturer

Nuvectra
  • Dirección del fabricante
    Nuvectra, 10675 Naples St NE, Blaine MN 55449-5802
  • Empresa matriz del fabricante (2017)
    Nuvectra Corporation
  • Source
    USFDA