Events

Retiro De Equipo (Recall) de Device Recall Medtronic SPECIFY

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 Neuromodulation.

¿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
    48705
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2241-2008
  • Fecha de inicio del evento
    2008-05-21
  • Fecha de publicación del evento
    2008-09-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71931
  • 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
    Lead kit for implanted spinal-cord stimulator (pain relief) - Product Code GZB
  • Causa
    Medtronic is recalling certain lots of model 3998 specify surgical lead kits due to a package mislabeling issue. the package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. recalled lots are to be returned for replacement or credit.
  • Acción
    In May 2008, a Product Recall letter was issued to customers. Medtronic Field Representatives are to contact customers with consigned or unregistered sold product to remove it and return it to Medtronic. A Leave-Behind letter will be provided to customers, explaining the issue and the reason for removal of product. Recalled devices will be returned for replacement or credit. The Medtronic representative will complete and return a Reply Card, which documents the notification of the customer. If you have questions or comments, contact your Medtronic representative.

Device

Device Recall Medtronic SPECIFY
  • Modelo / Serial
    V004442, V004456, V004457, V004541, V004644, V005789, V005838, V005884, V005952, V006010, V006011, V006497, V006610, V006732, V006888, V006937, V007136, V007224, V007342, V007451, V007565, V007729, V007781, V007911, V008174, V008257, V008387, V008638, V008639, V008729, V008902, V009060, V009191, V009278, V009352, V009353, V009630, V010099, V010124, V010125, V010366, V010367, V010602, V010744, V010896, V011057, V011091, V011215, V011257, V011299, V011406, V011457, V011552, V011610, V011627, V011860, V011958, V011977, V012040, V012123, V012202, V012238, V012260, V012411, V012571, V012618, V012935, V013158, V013231, V013331, V013489, V013615, V013745, V013787, V013837, V013862, V014190, V014320, V014426, V014454, V014660, V014785, V015071, V015166, V015327, V015626, V016195, V016445, V016489, V017182, V017731, V017927, V019145, V019452, V019569, V019909, V020188, V020688, V020904, V021560, V021753, V022880, V023339, V023517, V025268, V025500, V025707, V026020, V026436, V027462, V027804, V028474, V029383, V029983, V030442, V031317, V032070, V032560, V034825, V034832, V035769, V036156, V036810, V036857, V038530, V041066, V041365, V042627, V043757, V043759, V044336, V044850, V045723, V047365, V050371, V052566, V053142, V054607, V056045, V057371, V060415, V062321, V068860, V069647, V077531, V080086, V082162, V084570, V086942, V090294, V091959, V095777, V102426
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US distribution only to: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY
  • Descripción del producto
    Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Dirección del fabricante
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA