Events

Retiro De Equipo (Recall) de Medtronic Synchromed II Implantable Drug Infusion Pump

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
    78609
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0896-2018
  • Fecha de inicio del evento
    2017-08-09
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159884
  • 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
    Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
  • Acción
    Medtronic sent an Urgent Medical Device Recall letter dated September 2017, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed Customers Confirmation form. For questions contact Technical Services at 1-888-854-0978.

Device

Medtronic Synchromed II Implantable Drug Infusion Pump
  • Modelo / Serial
    US: CFN #: GTIN: PIN: 8637-20 00643169508149 863702012H 8637-40 00643169508156 863704012H OUS: CFN#: GTIN : PIN: 8637-20 00643169700901 863700221K 8637-20 00643169700918 863700222K 8637-20 00643169700925 863700223K 8637-20 00643169700932 863700224K 8637-20 00643169700949 863700225K 8637-20 00643169700956 863700226K 8637-20 00643169700963 863700227K 8637-20 00643169700970 863700228K 8637-20 00643169700987 863700229K 8637-20 00643169700994 863700230K 8637-20 00643169732247 863700241K 8637-20 00643169732254 863700242K 8637-20 00643169732261 863700243K 8637-20 00643169732278 863700244K 8637-20 00643169732285 863700245K 8637-20 00643169732292 863700246K 8637-20 00643169732308 863700247K 8637-20 00643169732315 863700248K 8637-20 00643169732322 863700249K 8637-20 00643169732339 863700250K 8637-40 00643169701007 863700231K 8637-40 00643169701014 863700232K 8637-40 00643169701021 863700233K 8637-40 00643169701038 863700234K 8637-40 00643169701045 863700235K 8637-40 00643169701052 863700236K 8637-40 00643169701069 863700237K 8637-40 00643169701076 863700238K 8637-40 00643169701083 863700239K 8637-40 00643169701090 863700240K 8637-40 00643169732346 863700251K 8637-40 00643169732353 863700252K 8637-40 00643169732360 863700253K 8637-40 00643169732377 863700254K 8637-40 00643169732384 863700255K 8637-40 00643169732391 863700256K 8637-40 00643169732407 863700257K 8637-40 00643169732414 863700258K 8637-40 00643169732421 863700259K 8637-40 00643169732438 863700260K
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY
  • Descripción del producto
    Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. || Product Usage: || The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Dirección del fabricante
    Medtronic Neuromodulation, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • 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