Medtronic Intrathecal Catheter, 8731SC

  • Model / Serial
    Lot No.: 0203850736, 0203851114, 0203851117, 0203851118, 0203853215, 0203853216, 0203855254, 0203856175, 0203859419, 0203859420, 0203862317, 0203862318, 0203862319, 0203862420, 0203862421, 0203862422, 0203862423, 0203862424, 0203862425, 0203862426, 0203862427, 0203863379, 0203863380, 0203867209, 0203867210, 0203867211, 0203867212, 0203870769, 0203870770, 0203870771, 0203870772, 0203870773, 0203870774, 0203877970, 0203879816, 0203879817, 0203879818, 0203879819, 0203879840, 0203879841, 0203880728, 0203884257, 0203886792, 0203886793, 0203886794, 0203889796, 0203889797, 0203889798, 0203893390, 0203893391, 0203893392, 0203893393, 0203893395, 0203893396, 0203893397, 0203893398, 0203893399, 0203893400, 0203893401, 0203893402, 0203893403, 0203893404, 0203893407, 0203895990, 0203895991, 0203895994, 0203896780, 0203896781, 0203896782, 0203899331, 0203899332, 0203899333, 0203899334, 0203900791, 0203903384, 0203903385, 0203909100, 0203909730, 0203915706, 0203915707, 0203915709, 0203915785, 0203915786, 0203920334, 0203920335, 0203920336, 0203920337, 0203920339, 0203921661, 0203921662, 0203921667, 0203921668, 0203921669, 0203921670, 0203921700, 0203921701, 0203921702, 0203927622, 0203928146, 0203931648, 0203931649, 0203931650, 0203931651, 0203931652, 0203931653, 0203931654, 0203931655, 0203931656, 0203931657, 0203931658, 0203931659, 0203931660, 0203931661, 0203931662, 0203938444, 0203938445, 0203938446, 0203942884, 0203942885, 0203942886, 0203944508, 0203944509, 0203944510, 0203944511, 0203944512, 0203944513, 0203944514, 0203944515, 0203944516, 0203948424, 0203948425, 0203949409, 0203949514, 0203949515, 0203950185, 0203950186, 0203950187, 0203950188, 0203950189, 0203950190, 0203950659, 0203950660, 0203951458, 0203951511, 0203951761, 0203952317, 0203952318, 0203952319, 0203952320, 0203952321, 0203952322, 0203953292, 0203953450, 0203954343, 0203954344, 0203954345, 0203954346, 0203954347, 0203954348, 0203954349, 0203954350, 0203955107, 0203955108, 0203957416, 0203957438, 0203957543, 0203958179, 0203958785, 0203958786, 0203958787, 0203959200, 0203959201, 0203959202, 0203959204, 0203959205, 0203959206, 0203959207, 0203959208, 0203959209, 0203959210, 0203959211, 0203959212, 0203959213, 0203959214, 0203960345, 0203960346, 0203960347, 0203960567, 0203961628, 0203961629, 0203961630, 0203961631, 0203962326, 0203962327, 0203962328, 0203962334, 0203962758, 0203962759, 0203962760, 0203962761, 0203962762, 0203962763, 0203962764, 0203962765, 0203963702, 0203964041, 0203964176, 0203964177, 0203966654, 0203966655, 0203966656, 0203966657, 0203967746, 0203967747, 0203969526, 0203969527, 0203969568, 0203972088, 0203972147, 0203972148, 0203972149, 0203972150, 0203972496, 0203972497, 0203976200, 0203976889, 0203977018, 0203977019, 0203977487, 0203977488, 0203978070, 0203978071, 0203978072, 0203978073, 0203978309, 0203978571, 0203978572, 0203978573, 0203978574, 0203978575, 0203979297, 0203981130, 0203983193, 0203984103, 0203984147, 0203984148, 0203987610, 0203987611, 0203989924, 0203989996, 0203989997, 0203990391, 0203990392, 0203990393, 0203990394, 0203990395, 0203992290, 0203993215, 0203993216, 0203995354, 0203995355, 0203995356, 0203995357, 0203995769, 0203995770, 0203995771, 0203997376, 0203997377, 0203997378, 0203999236, 0203999303, 0204000008, 0204000295, 0204000296, 0204000297, 0204000298, 0204003660, 0204004081, 0204004082, 0204004083, 0204004084, 0204004085, 0204004086, 0204004087, 0204004088, 0204004089, 0204004090, 0204004091, 0204004092, 0204004093, 0204004094, 0204004096, 0204004097, 0204004098, 0204004099, 0204004365, 0204004366, 0204006194, 0204006195, 0204006196, 0204006197, 0204006198, 0204006199, 0204006200, 0204006201, 0204006205, 0204006206, 0204007034, 0204008280, 0204008281, 0204008282, 0204008446, 0204008657, 0204008658, 0204008660, 0204009383, 0204009384, 0204009385, 0204009386, 0204009387, 0204009388, 0204009389, 0204009390, 0204009391, 0204009392, 0204012287, 0204012385, 0204012386, 0204012387, 0204016718, 0204016719, 0204016733, 0204016764, 0204016911, 0204016912, 0204016916, 0204016917, 0204016918, 0204016919, 0204016920, 0204016921, 0204018192, 0204018193, 0204018194, 0204018195, 0204018196, 0204018197, 0204018198, 0204018199, 0204018200, 0204018201, 0204018202, 0204018203, 0204018998, 0204019664, 0204021155, 0204022076, 0204022077, 0204022080, 0204022081, 0204023298, 0204023299, 0204023300, 0204025166, 0204025169, 0204025170, 0204025171, 0204025172, 0204025173, 0204027136, 0204027137, 0204027138, 0204027139, 0204027140, 0204027141, 0204027143, 0204027144, 0204027145, 0204027146, 0204027147, 0204027148, 0204027149, 0204027150, 0204027151, 0204027152, 0204027153, 0204027154, 0204027155, 0204032727, 0204036836, 0204037008, 0204037009, 0204037010, 0204037011, 0204039746, 0204041013, 0204042310, 0204042311, 0204042312, 0204042313, 0204042490, 0204045262, 0204045263, 0204045264, 0204045265, 0204045266, 0204045267, 0204046771, 0204046772, 0204046773, 0204049190, 0204049191, 0204049192, 0204049193, 0204049194, 0204051213, 0204054698, 0204054699, 0204054779, 0204056270, 0204056271, 0204056650, 0204056651, 0204056652, 0204061469, 0204062078, 0204062813, 0204062814, 0204062815, 0204062816, 0204064265, 0204066655, 0204066656, 0204066657, 0204069130, 0204069131, 0204069132, 0204069133, 0204069273, 0204069274, 0204071106, 0204071762, 0204073186, 0204073187, 0204073188, 0204073189, 0204073190, 0204073191, 0204073192, 0204077041, 0204077042, 0204077043, 0204077485, 0204077486, 0204078775, 0204078776, 0204079473, 0204079474, 0204079475, 0204079476, 0204079477, 0204079478, 0204080052, 0204083246, 0204083247, 0204083248, 0204086957, 0204086958, 0204086959, 0204088410, 0204088411, 0204089084, 0204089085, 0204089086, 0204089770, 0204092017, 0204092130, 0204092131, 0204092132, 0204092133, 0204092134, 0204092135, 0204092136, 0204094160, 0204094168, 0204094169, 0204094170, 0204094171, 0204094172, 0204094972, 0204094973, 0204094975, 0204097445, 0204097446, 0204097447, 0204099457, 0204099458, 0204099459, 0204099554, 0204099555, 0204101366, 0204102607, 0204102608, 0204104625, 0204104626, 0204104627, 0204104692, 0204104693, 0204106120, 0204106121, 0204106523, 0204109871, 0204109872, 0204110008, 0204110009, 0204110010, 0204110011, 0204110012, 0204110013, 0204110014, 0204111580, 0204111876, 0204112648, 0204112649, 0204112650, 0204112651, 0204114365, 0204114366, 0204114367, 0204114601, 0204114602, 0204116079, 0204116080, 0204116081, 0204116082, 0204116083, 0204116084, 0204116085, 0204116086, 0204117323, 0204117324, 0204117325, 0204118457, 0204118458, 0204118459, 0204119305, 0204119306, 0204119752, 0204119753, 0204132071, 0204132072, 0204135600, 0204136295, 0204136296, 0204136297, 0204136298, 0204136299, 0204136300, 0204136301, 0204136302, 0204136303, 0204136304, 0204136305, 0204136306, 0204136307, 0204136308, 0204136309, 0204136310, 0204136311, 0204136312, 0204136313, 0204136314, 0204136315, 0204136316, 0204136317, 0204136318, 0204136319, 0204136320, 0204136321, 0204136322, 0204136323, 0204136324, 0204136325, 0204136326, 0204136327, 0204136328, 0204139429, 0204139456, 0204139610, 0204139611, 0204139612, 0204139613, 0204139614, 0204141266, 0204142025, 0204144525, 0204144526, 0204144643, 0204145893, 0204146651, 0204146652, 0204146653, 0204146654, 0204147342, 0204147343, 0204149863, 0204149864, 0204149865, 0204149866, 0204149867, 0204149868, 0204149869, 0204150832, 0204151929, 0204152832, 0204152833, 0204152834, 0204152836, 0204152837, 0204152838, 0204152839, 0204153733, 0204153734, 0204153735, 0204153736, 0204154396, 0204154397, 0204154398, 0204154399, 0204155090, 0204155091, 0204157049, 0204157050, 0204157051, 0204157052, 0204157053, 0204157054, 0204157055, 0204157056, 0204157057, 0204157058, 0204157065, 0204157247, 0204157248, 0204157249, 0204160955, 0204160956, 0204162983, 0204162984, 0204163022, 0204163023, 0204163024, 0204163025, 0204163050, 0204163167, 0204163168, 0204164728, 0204165584, 0204166333, 0204166334, 0204166335, 0204166336, 0204168670, 0204168671, 0204168672, 0204168673, 0204168674, 0204170110, 0204170846, 0204171511, 0204174125, 0204174126, 0204174127, 0204174128, 0204174129, 0204175292, 0204175293, 0204175854, 0204175855, 0204177041, 0204177096, 0204177097, 0204177098, 0204177099, 0204177100, 0204179185, 0204179186, 0204183491, 0204183492, 0204189084, 0204189634, 0204194579, 0204194580, 0204194581, 0204194582, 0204194583, 0204194584, 0204194978, 0204194979, 0204194980, 0204194981, N258004001, N258004002, N258004003, N258004004, N258004005, N258007001, N258007002, N258007003, N258007004, N258007005, N258007006, N258007007, N258007008, N258007009, N258007010, N258007011, N258007012, N258097001, N258097002, N258097003, N258097004, N258097005, N258097006, N258097007, N258097008, N258097009, N258097010, N258097011, N258097012, N258097013, N258097014, N258097015, N258105001, N258105002, N258109001, N258109002, N258109003, N258109004, N258109005, N258109006, N258109007, N258109008, N258109009, N258109010, N258109011, N258109012, N258109013, N258109014, N258109015, N258110001, N258111001, N258112001, N258112002, N258112003, N258112004, N258112005, N258112006, N258112007, N258112008, N258112009, N258112010, N258112011, N258112012, N258112013, N258112014, N258112015, N258116001, N258116002, N258116003, N258116004, N258116005, N258116006, N258116007, N258116008, N258116009, N258116010, N258116011, N258116012, N258116013, N258116N01, N258383001, N258383002, N258383003, N258383004, N258383005, N258383006, N258383007, N258383008, N258383009, N258383010, N258383011, N258383012, N258383013, N258383014, N258383015, N259095001, N259095002, N259095003, N259095004, N259095005, N259095006, N259095007, N259095008, N259095009, N259095010, N259095011, N259095012, N259095013, N259243001, N259244001, N259244002, N259244003, N259244004, N259244005, N259245001, N259245002, N259245003, N259245004, N259245005, N259245006, N259285001, N259285002, N259285003, N259906001, N259906002, N259906003, N259906004, N259906005, N259906006, N259906007, N259906008, N259906009, N259906010, N259906011, N259906012, N259906013, N259906014, N259906N01, N259908001, N259908002, N259908003, N259908004, N259908005, N259908006, N259908007, N259908008, N259908009, N259908010, N259908011, N259908012, N259908013, N259908014, N259908015, N260264001, N260264002, N260264003, N260264004, N260264005, N260264006, N260264007, N260264008, N260264009, N260264010, N260264011, N260264012, N260264013, N260264014, N260264015, N260812001, N260812002, N260812003, N260812004, N260812005, N260812006, N260812007, N260812008, N260812009, N260812010, N260812011, N260812012, N260812013, N260812014, N260812015, N260949001, N260949002, N260949003, N260953001, N260953002, N260953003, N260953004, N260953005, N260953006, N260953007, N260953008, N260953009, N260953010, N260953011, N260953012, N261186001, N261186002, N261186003, N261186004, N261186005, N261186006, N261186007, N261186008, N261186009, N261186010, N261189001, N261189002, N261189003, N261189004, N261189005, N261581001, N261581002, N261581003, N261581004, N261581005, N261581006, N261583001, N261583002, N261583003, N261583004, N261583005, N261583006, N261583007, N261583008, N261583009, N261798001, N261798002, N261798003, N261798004, N261798005, N261798006, N261798007, N261798008, N261798009, N261798010, N261798011, N261798012, N261798013, N261798014, N261798015, N262128001, N262128002, N262128003, N262128004, N262128005, N262128006, N262128007, N262128008, N262128009, N262128010, N262128011, N262133001, N262133002, N262133003, N262133004, N262471001, N262471002, N262471003, N262471004, N262471005, N262471006, N262471007, N262471008, N262471009, N262471010, N262471011, N262471012, N262471013, N262471014, N262471015, N262473001, N262473002, N262473003, N262473004, N262473005, N262473006, N262473007, N262473008, N262473009, N262473010, N262473011, N262473012, N262473013, N262473014, N262475001, N263007001, N263007002, N263007003, N263007004, N263007005, N263007006, N263007007, N263007008, N263007009, N263007010, N263007011, N263007012, N263007013, N263007014, N263007015, N263011001, N263011002, N263011003, N263011004, N263011005, N263012001, N263012002, N263012003, N263012004, N263012005, N263012006, N263012007, N263012008, N263012009, N263012010, N263012011, N263012012, N263012013, N263012014, N263013001, N263013002, N263013003, N263013004, N263013005, N263013006, N263013007, N263013008, N263013009, N263013010, N263013011, N263018001, N263018002, N263018003, N263018004, N263018005, N263018006, N263018007, N263018008, N263018009, N263020001, N263020002, N263020003, N263020004, N263020005, N263020006, N263020007, N263020008, N263020009, N263020010, N263020011, N263020012, N263020013, N263030001, N263031001, N263031002, N263146001, N263146002, N263146003, N263146004, N263146005, N263146006, N263146007, N263146008, N263146009, N263146010, N263146011, N263146012, N263146013, N263146014, N263146015, N263148001, N263148002, N263148003, N263148004, N263157001, N263157002, N263157003, N263157004, N263157005, N263157006, N263157007, N263157008, N263157009, N263157010, N263157011, N263157012, N263157013, N263163001, N263163002, N263163003, N263163004, N263163005, N263163006, N263163007, N263163008, N263163009, N263163010, N263163011, N263163012, N263163013, N263163014, N263163015, N263167001, N263167002, N263167003, N263167004, N263167005, N263167006, N263171001, N263171002, N263171003, N263171004, N263171005, N263171006, N263171007, N263171008, N263171009, N263171010, N263171011, N263171012, N263171013, N263171014, N263172001, N263172002, N263172003, N263172004, N263172005, N263172006, N263172007, N263172008, N263172009, N263172010, N263172011, N263172012, N263177001, N263177002, N263177003, N263177004, N263177005, N263177006, N263178001, N263178002, N263178003, N263178004, N263178005, N263178006, N263178007, N263178008, N263178009, N264154001, N264154002, N264154003, N264154004, N264154005, N264154006, N264157001, N264157002, N264158001, N264158002, N264158003, N265448001, N265448002, N265448003, N265448004, N265448005, N265448006, N265448007, N265448008, N265448009, N265448010, N265448011, N265448012, N265448013, N265448014, N265448015, N265451001, N265451002, N265451003, N265451004, N265497001, N265497002, N265497003, N265497004, N265497005, N265497006, N265497007, N265497008, N265502001, N265502002, N265502003, N265502004, N265502005, N265502006, N265502007, N265512001, N265512002, N265512003, N265512004, N265512005, N265512006, N265512007, N265512008, N265512009, N265512010, N265512011, N265512012, N265512013, N265512014, N265512015, N265515001, N265515002, N265515003, N265515004, N265516001, N265516002, N265516003, N265516004, N265516005, N265516006, N265516007, N265518001, N265518002, N265518003, N265518004, N265519001, N265519002, N265519003, N265519004, N265519005, N265519006, N265519007, N265519008, N265519009, N265519010, N265519011, N265519012, N265519013, N265519014, N265519015, N265521001, N265521002, N265521003, N265521004, N265521005, N265521006, N265521007, N265521008, N265521009, N265522001, N265522002, N265522003, N265522004, N265522005, N265522006, N265531001, N265533001, N265533002, N265533003, N265533004, N265533005, N265533006, N265533007, N265533008, N265533009, N265533010, N265533011, N265700001, N265700002, N265700003, N265700004, N265700005, N265700006, N265700007, N265700008, N265700009, N265700010, N265700011, N265700012, N265700013, N265700014, N265700015, N265700016, N265700017, N265702001, N265702002, N265702003, N265702004, N265702005, N265702006, N265702007, N265703001, N265703002, N265703003, N265703004, N265703005, N265703006, N265703007, N265703008, N265703009, N266847001, N266847002, N266847003, N266847004, N266847005, N266859001, N266859002, N266859003, N266859004, N266859005, N266859006, N266859007, N266859008, N266859009, N266859010, N266859011, N266862001, N266862002, N266862003, N266862004.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    AL, CA, CO, CT, FL, GA, HI, ID. IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, VA, WA, WI, WV, WY. OUS to include: Argentina, Austria, Belgium, Canada, Chile, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, San Marino, Jordan, Lithuania, Netherlands, Norway, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, United Arab Emirates, United Kingdom.
  • Product Description
    Medtronic Intrathecal Catheter, 8731SC with sutureless connector. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 The implantable Medtronic Model 8731SC 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 8731SC catheter. The catheter connects to the pump at the catheter port. || To deliver parenteral drugs to the intrathecal space. The needle is used to facilitate the placement of the catheter. The needle is inserted percutaneously into the intrathecal. The needle stylet is then removed to confirm the needle placement through observing backflow of cerebrospinal fluid (CSF) through the needle. The needle stylet prevents tissue coring and also minimizes loss of CSF. The spinal segment tip of the catheter is inserted through the needle until the catheter is advanced to the desired location. Once the catheter position is verified through fluoroscopy, the needle is carefully removed and discarded.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic, Inc. - Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 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
    USFDA