Retiro De Equipo (Recall) de Medtronic Ascenda(R) Intrathecal Catheter

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
    78406
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0537-2018
  • Fecha de inicio del evento
    2017-09-21
  • Fecha de publicación del evento
    2018-02-06
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Causa
    There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.
  • Acción
    Medtronic on September 21, 2017, initiated a medical device recall and sent the following via mail (with delivery confirmation) to the consignees. In addition to the mailing, Medtronic field representatives may personally visit the accounts to provide the recall notification, assist the customer as necessary with locating and returning affected product(s), and verify that the customer has or will respond to Medtronic with the Customer Confirmation Form. For further questions, please call (800) 707-0933.

Device

  • Modelo / Serial
    (a) Model 8780: N740471001, N740482002, N740507001, N741669001, N741918005, N742124002, N742180002, N742214002, N743749002, N747547001, N740471002, N740482003, N740507002, N741669002, N742077001, N742124004, N742180003, N742214003, N743749004, N747547003, N740471003, N740482004, N740507003, N741669003, N742077002, N742124005, N742180004, N742214004, N743749005, N747547004, N740471004, N740482005, N740507004, N741669004, N742077003, N742124006, N742180006, N742214005, N743749006, N747547005, N740471005, N740482006, N740507005, N741669005, N742077004, N742143001, N742184003, N742942001, N743773001, N740471006, N740496001, N740507006, N741669006, N742077005, N742143002, N742184004, N742942002, N743773002, N740476001, N740496003, N740508001, N741677001, N742077006, N742143005, N742184005, N742942003, N743773003, N740476002, N740496004, N740508002, N741677002, N742088001, N742143006, N742184006, N742942004, N743773004, N740476004, N740496005, N740508003, N741677004, N742088002, N742151001, N742197001, N742942005, N743773005, N740476006, N740496006, N740508004, N741677006, N742088003, N742158002, N742197002, N742977001, N743800006, N740477001, N740500001, N740508006, N741688001, N742088004, N742158003, N742197003, N742977002, N744024001, N740477002, N740500003, N740511001, N741688002, N742088005, N742158004, N742197004, N742977003, N744024002, N740477003, N740500004, N740511002, N741688003, N742088006, N742158005, N742197005, N742977004, N744024003, N740477004, N740500005, N740511003, N741688004, N742093002, N742158006, N742197006, N742977005, N744024004, N740477005, N740500006, N740511004, N741688005, N742093004, N742172001, N742211001, N743157002, N744024005, N740477006, N740506001, N740511005, N741688006, N742093005, N742172002, N742211002, N743157003, N744024006, N740479003, N740506002, N740540002, N741918001, N742112003, N742172003, N742211003, N743157004, N747546001, N740479004, N740506003, N740540003, N741918002, N742112004, N742172004, N742211004, N743157005, N747546003, N740479005, N740506004, N740540005, N741918003, N742112006, N742172005, N742211005, N743157006, N747546004, N740482001, N740506006, N740540006, N741918004, N742124001, N742180001, N742214001, N743749001, N747546005   (b) Model 8781: N745579001, N745579002, N745579005, N745579006, N746858001  (c) Model 8784: N745557001, N745557002, N745557003, N745557004, N745557005
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Medtronic Ascenda(R) Intrathecal Catheter, Models: || (a) 8780, UDI: 00643169202122, 00643169783027 || (b) 8781, UDI: 00643169202139 || (c) 8784, UDI: 00643169202153 || The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Medtronic Neuromodulation, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • Empresa matriz del fabricante (2017)
  • 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