Events

Retiro De Equipo (Recall) de NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces Pulse;Response;Neuro

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 Xomed, 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
    63008
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2343-2012
  • Fecha de publicación del evento
    2012-09-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112304
  • 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, electrical, evoked response - Product Code GWF
  • Causa
    In january 2010, medtronic issued a recall of medtronic nim 3.0 patient interfaces after medtronic identified a trend of open channel conditions (signal loss from the electrode). when the nim 3.0 detects the signal loss from the electrode (i.E. open channel), it fails the electrode check and provides an audible and visual warning to the user which could also create a delay in the surgical procedu.
  • Acción
    The firm, Medtronic USA, Inc., sent an "URGENT Product Recall Notification" letter dated September 27, 2010, to its U.S. and International customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify their receipt of this notice and complete and sign the Product Replacement checklist form indicating that their sales representative has completed the replacement of their devices and fax to 1-651-367-8055. U.S. Customer Units - replacement kits with their contents will be provided to each Area Sales Manager (ASM) for each customer along with documentation of serial number units to be replaced. Each ASM will be responsible for delivering a replacement unit(s) and picking up and returning each of their customer's units using the pre-labeled replacement kit boxes. International Customer Units- International units, depending on the geography will either be replaced or repaired and returned. If replacement is planned, the International Business Manager (IBM) will receive replacement kits as described for the U.S. In those geographies where devices will be repaired and returned, kits with the following contents will be sent to IBM's along with documentation of serial number units to be repaired. Foreign distribution: In the larger territories (i.e. Australia, Japan, Canada, EMEA-Europe, Middle East, Africa), repairs/rework were handled at the Medtronic facilities in those geographic areas. In the smaller geographic areas (Singapore, Thailand, Hong Kong, Korea, Latin America ), where there were limited sales, devices were returned to the U.S. In all cases (large and small geographic areas), devices were returned via a Medtronic entity (sales office or distribution center). If you have any questions regarding the subject Actron or the content of this letter, contact the Distinguished Regulatory Affairs Advisor at 904-279-7532.

Device

NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces Pulse;Response;Neuro
  • Modelo / Serial
    8253410 (Neuro). All Serial Numbers.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries of: Australia, Austria, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Lebanon, Libya, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudia Arabia, Singapore, Slovak, Spain, SRI Lanka, Sweden, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Interfaces subject to recall: || Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). || LABELING: || Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA***Rx Only***Lot***SN:***" || Top of unit is labeled in part: "***NIM-Response 3.0***Medtronic***" || Bottom/Underside of unit is labeled in part: "***5X20mm FA.L., 32mA. 250VAC***REF***MEDTRONIC XOMED INC. JACKSONVILLE, FL USA***" || Cord is labeled in part: "***Ref.***Mfg Date***Sn***" || The NIM 3.0 Patient Interfaces [REF #'s 8253210 (Pulse), 8253200 (Response), 8253410 (Neuro)] is an EMG Nerve Integrity Monitor intended for locating and identifying cranial and peripheral motor and mixed motor-sensory nerves during surgery, including spinal cord and spinal nerve roots.
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Dirección del fabricante
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA