Medtronic Neuromodulation

What is this?

Description

11 devices in the database

  • Model / 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
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    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.
  • Model / Serial
    Serial numbers: NKM724776H, NKM724782H, NKM724785H,  NKM724790H, NKM724802H, NKM724843H.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of: MA, NC, OH, and TX.
  • Product Description
    Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. || The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
  • Model / Serial
    Serial Numbers are in the following format: "N" + 9 digits (e.g. N12345001. Product beginning with the following letter/number combinations are affected: N464184, N464200, N464206, N464254, N464257, N464258, N464262, N464263, N464264, N464271, N464693, N464703, N464708, N464725, N464727, N464730, N464734, N464736, N464738, N464742, N464746, N464750, N464752, N464841, N464924, N464930, N464995, N464995, N465020, N465038, N465063, N465065, N465073, N465082, N465088, N465091, N465094, N465111, N465125, N465129, N465131, N465136, N465138, N465144, N465145, N465146, N465148, N465150, N466065, N466067, N466067, N466068, N466069, N466071, N466072, N466075, N466134, N466167, N466177, N466196, N466201, N466240, N466244, N466259, N466289, N466290, N466291, N466306, N466368, N466390, N466392, N466394, N466398, N466399, N466631, N466639, N466645, N466678, N466678, N466754, N466758, N466761, N466886, N466897, N466901, N466902, N466911, N466914, N467103, N467109, N467113, N467114, N467116, N467126, N467138, N467171, N467180, N467183, N467192, N467193, N467194, N467195, N467197, N467198, N467203, N467204, N467206, N467209, N467351, N467351, N467352, N467355, N467356, N467357, N467395, N467399, N467401, N467402, N467407, N467444, N467451, N467453, N467454, N467563, N467568, N467570, N467601, N467606, N467608, N467609, N467611, N467612, N467614, N467618, N467621, N467626, N468288, N468343, N468401, N468404, N468406, N468406, N468448, N468494, N468500, N468507, N468510, N468511, N468514, N468516, N468519, N468522, N468574, N468580, N468621, N468622, N468624, N468626, N468641, N469182, N469262, N469332, N469360, N469360, N469388, N469420, N469422, N469428, N469431, N469433, N469434, N469436, N469438, N469440, N469446, N469447, N469449, N469452, N469460, N469465, N469466, N469469, N469474, N469478, N469507, N469511, N469530, N469533, N469549, N469579, N469583, N469586, N469588, N470163, N470197, N470234, N470303, N470307, N470401, N470408, N470414, N470420, N470424, N470453, N470459, N470919, N470923, N470929, N470931, N470931, N470934, N470938, N470940, N470941, N470951, N470953, N470954, N471442, N471443, N471446, N471447, N471448, N471449, N471487, N471488, N471490, N471490, N471491, N471764, N471791, N471840, N471853, N471856, N471860, N471863, N471864, N471865, N471866, N471870, N471871, N471875, N471880, N472310, N472326, N472333, N472336, N472342, N472345, N472347, N472857, N472861, N472866, N472868, N472873, N472875, N472876, N472878, N472882, N472885, N472886, N472890, N472894, N472900, N472905, N473140, N473144, N473148, N473154, N473156, N473176, N473178, N473180, N473202, N473207, N473211, N473221, N473222, N473223, N473228, N473230, N473311, N473311, N473323, N473377, N473401, N473426, N473438, N473492, N473493, N473989, N473996, N473999, N474001, N474005, N474006, N474007, N474010, N474018, N474019, N474023, N474027, N474037, N474038, N474047, N474047, N474421, N474423, N474427, N474431, N474433.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of AL,AR,AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of Austria, Belgium, Cyprus, Denmark, France, Germany, Iraq, Italy, Lebanon, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Uruguay.
  • Product Description
    Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. || The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Ascenda Intrathecal Catheter.
  • Model / Serial
    Lot numbers: 082605614, 082601414, 082602014, 082634313, 082630913, 082629713, 082629613, 082626913, 082623113, 082621413, and 082618213.   EXPANDED 10/02/2014 Lot Numbers: 082616214, 082616314, 082618314, and 082618414.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom.
  • Product Description
    Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. || For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
  • Model / Serial
    N457062003
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed in the state of CT.
  • Product Description
    Medtronic Model 8780 Ascenda Intrathecal Catheter. || The implantable Medtronic Model 8780 Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8780 Ascenda Intrathecal Catheter.
6 more

15 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    NIDFSINVIMA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    NIDFSINVIMA
10 more