Retiro De Equipo (Recall) de Device Recall Medtronic Restore Neurostimulator

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 Medtronic Inc, Neurological & Spinal Division.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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, Implanted (Pain Relief) - Product Code GZB
  • Causa
    A limited number of model 37711 restore neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. this anomaly does not affect patient safety. this anomoly can be corrected by reprogramming the restore neurostimulator using specific software.
  • Acción
    A 'Customer Communication' letter was sent to Medtronic field personnel to hand-carry into the affected accounts; customer contact began on 11/22/2005. The letter explains the patients implanted with these devices likely will only be able to recharge their neurostimulator to about 80-90% of a full charge. This anomaly does not affect device safety or effectiveness but Medtronic will re-program them upon request for customer satisfaction. The letter will be followed by scheduled on-site visit to reset the internal memory parameter of the neurostimulator.


  • Modelo / Serial
    NJH701951H thru NJH801963H, NJH701965H, NJH701967H thru NJH701969H, NJH701971H thru NJH701975H, NJH701978H thru NJH701986H, NJH702007H, NJH702008H, NJH702028H, NJH702029H, NJH702032H, NJH702033H, NJH702035H, NJH702036H, NJH702038H, NJH702039H, NJH702044H, NJH702045H, NJH702144H, NJH702145H, NJH702146H, NJH702150H, NJH702152H, NJH702153H, NJH702157H, NJH702158H, NJH702159H, NJH702160H, NJH702162H, NJH702163H, NJH702164H, NJH702166H, NJH702168H, NJH702169H, NJH702171H thru NJH702175H, NJH702183H, NJH702184H, NJH702213H, NJH702215H, NJH702216H, NJH702263H, NJH702324H, NJH702425H, NJH702427H, NJH702428H, NJH702429H, NJH702434H, NJH702436H, NJH702438H, NJH702439H, NJH702441H, NJH702443H, NJH702447H, NJH702451H, NJH702452H, NJH702455H, NJH702458H, NJH702487H, NJH702765H, NJH702772H, NJH702809H, NJH702834H, NJH702852, NJH702862H, NJH702863H, NJH702919H, NJH702980, NJH702982H, NJH702990H, NJH702993H, NJH702999H, NJH703001H
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide (AZ, CA, FL, ID, IL, IN, KS, KY, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, and WI).
  • Descripción del producto
    Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.
  • Manufacturer


  • Dirección del fabricante
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source