Devices

Medtronic Ascenda(R) Intrathecal Catheter

  • 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
    General Hospital and Personal Use Devices
  • 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
    Medtronic Neuromodulation
  • 1 Event

Fabricante

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