Devices

INSIGNIA Ultra and NEXUS Ultra

  • Model / Serial
    All serial numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Arab Emerites, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan ROC, Thailand, Turkey, United Kingdom, Urguay and Venezuela
  • Product Description
    Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Guidant Corporation
  • 1 Event

Manufacturer

Guidant Corporation
  • Manufacturer Address
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall INSIGNIA Ultra and NEXUS Ultra
  • Model / Serial
    model 1190, serial numbers: 135575, 135576, 135577, 135597, 135598, 135600, 135601, 135610, 135642, 135643,  135645, 135651, 135654, 135655, 135656, 135657, 135659,  135663, 135664, 135665, 135666, 135667, 135668, 135671,  135672, 135675, 135676, 135677, 135678, 135679, 135682,  135683, 135691, 135693 thru 135732, 135734 thru 135755, 135757 thru 135806, 135808 thru 135816, 135818 thru 135830, 135832 thru 135843, 135845 thru 135934, 135936 thru 135969, 135972, 135973, 135975, 135977 thru135990, 136009, 136012 thru 136033, 136038 thru 136045, 136054 thru 136063, 136065 thru 136068, 136070 thru 136078, 136081, 136086, 136087, 136090 thru 136114, 136118 thru 136149, 136153, 136156 thru 136163, 136165 thru 136193, 136195 thru 136201, 136204, 136205, 136207, 136210, 136211, 136214 thru 136228, 136230 thru 136246, 136248 thru 136251, 136256 thru 136384, 136386 thru 136399, 136401 thru 136517, 136519 thru 136567, 136569 thru 136573, 136575 thru 136619, 136621 thru 136673, 136675 thru 136712, 136714 thru 136770, 136773, 136774, 136776 thru 136789, 136791, 136794, 136796, 136799, 136800,  136801, 136805, 136807, 136810, 136814, 136816, 136817,  136819, 136822, 136823, 136826, 136827, 136829 thru  136832, 136834, 136835, 136836, 136837, 136841, 136845 thru 136850, 136854 thru 136857, 136862 thru 136865, 136870 thru 136880, 136882 thru 136901, 136905 thru 136913, 136918 thru 136923, 136926 thru 136937, 136943 thru 136952, 136954 thru 136966, 136968 thru 136980, 136983, 136984, 136986 thru 137005, 137011 thru 137013,  137024, 137026, 137028, 137029, 137051, 137054, 137055,  137060, 137070, 137072, 137073, 137078, 137079, 137085,  137086 thru 137093, 137100, 137101, 137102, 137105,  137106, 137107, 137109, 137110, 137116 thru 137121,  137127, 137130, 137131, 137133, 137134, 137142, 137144 thru 137147, 137151, 139320 thru 137333, 137335 thru 137444, 137446 thru 137527, 137529 thru 137636, 137638 thru 137889, 137892 thru 137911, 137916 thru 137947, 137955 thru 137958, 137961, 137962, 137965, 137966,  137968, 137969, 137970, 137975, 137976 thru137982,  137987 thru 137994, 137996, 138001 thru 138009, 138011,  138015 thru 138019, 138022, 138023, 138028, 138029,  138052 thru 138055, 138060 thru 138063, 138067, 138071 thru 138075, 138080 thru 138090, 138092, 138093, 138096 thru 138116, 138119, 138128, 138129, 138145, 138168, 138169 138170, 138172 thru 138185, 138187, 138188, 138189,  138191 thru 138196, 138199, 138200, 138201, 138205,  138206, 138207, 138208, 138209, 138210, 138211, 138229,  138233, 138234, 138235, 138310, 138311, 138353, 138364,  138366, 138367, 138368, 138370, 138371, 138375, 138380,  138427, 138428, 138453, 138456, 138457, 138460, 138461,  138462, 138463, 138474, 138475, 138477, 138478, 138489, 138540, 138541, 138542, 138543, 138544, 138545, 138547,  138552, 138554, 138555, 138556, 138558, 138559, 138581, 138582, 138588 thru 138601, 138604, 138605, 138607 thru  138608, 138613, 138622, 138623, 138624, 138627, 138628,  138632, 138633, 138634, 138635, 138640, 138643, 138644,  138645, 138646, 138647, 138648, 138650, 138651, 138653,  138654, 138655, 138657, 138662 thru 138667, 138674, 138675, 138676, 138677, 138680, 138681, 138683, 138684,  138688, 138689, 138690, 138691, 138692, 138693, 138694,  138695, 138705, 138707, 138737, 138738, 138739, 138781,  138782, 138792, 138802, 138803, 138804, 138815, 138816,  138817, 138884, 138885, 138886, 138888, 138889, 138890, 138895, 138907, 138910, 138912, 138933, 138936, 138937,  138938, 138939, 138940, 138941, 138942, 138943, 138948,  138949, 138950, 138951, 138952, 138953, 138954, 138955,  138973, 138974, 138975, 138979, 138982, 138983, 138984,  138985, 138988, 139000 thru 139003, 139006, 139012, 139014, 139015, 139028, 139029, 139031 thru 139035,  139049, 139050, 139054, 139055, 139066, 139067, 139071,  139099 thru 139102, 139104, 139105, 139124, 139125,  139126, 139127, 139136 thru 139143, 139149, 139150,  139151, 139152, 139156 thru 139219, 139222 thru 139231,  139233 thru 139280, 139283 thru 139310, 139312 thru 139410, 139414, 139416, 139419 thru 139456, 139458 thru 139486, 139488 thru 139523, 139525 thru 139554, 139556, 139558, 139559, 139578-139583, 139586, 139590, 139593, 139594, 139595, 139604, 139607, 139612 thru 139774, 139776 thru 139810, 139812 thru 139949, 139951 thru 139961, 139963 thru 139974, 139976 thru 140057, 140059 thru 140200, 140202 thru 140300, 140302 thru 140307, 140309 thru140441, 140443 thru 140456, 140459 thru 140484, 140486 thru 140503, 140505 thru 140570, 140572 thru 140631, 140633 thru 140660, 140662 thru 140864, 140866 thru 140901, 140903 thru 141038, 141040 thru 141114, 141116 thru 141171, 141173 thru 141249, 141251 thru 141348, 141350 thru 141358, 141360 thru 141679, 141682 thru 141691, 141693 thru 141724, 141726 thru 141729, 141731 thru 141742, 141744, 141745, 141749, 141750, 141752 thru 141760, 141762, 141763, 141766, 141767, 141768, 141769, 141772, 141773, 141774, 141778, 141779, 141780, 141783, 141828, 141829, 141830, 141831,141835, 141837, 141838, 141839, 141841, 141842, 141843, 141844, 141845, 141846, 141848 thru 141858, 141860 thru 141870, 141872, 141873, 141874, 141875, 142232, 142233, 142244, 142245, 142246, 142247, 898703.   model 1290, serial numbers: 737576 thru 737581, 737584, 737673, 737681 thru 737683, 737685 thru 737689, 737693, 737697, 737698, 737701, 737702, 737709 thru 737713, 737717, 737721, 737722, 737724, 737752, 737753, 737761 thru 737763, 737766, 737773, 737775, 737778, 737786, 737787,737789, 737790, 737797, 737798, 737802, 737809 thru 737811, 737814, 737822, 737823,737826, 737831, 737838, 737839, 737850, 737903, 737905, 737907, 737910, 737917, 737919, 737927, 737928, 737930, 737931, 737933, 737934,737941 thru 737943, 737952, 737968, 737972, 737973, 737977, 737978, 737990, 738196, 738197, 738199, 738200, 738279 thru 738281, 738286, 738292 thru 738294, 738296, 738297, 738299, 738304, 738305,738313, 738316, 738317, 738319 thru 738350, 738352 thru 738376, 738378 thru 738383, 738385 thru 738393, 738395 thru 738455, 738457 thru 738481, 738483 thru 738504, 738506, 738507, 738509, 738510, 738513 thru 738519, 738522, 738524, 738526, 738529 thru 738540, 738542, 738543, 738545, 738546, 738553 thru 738556, 738559, 738562 thru 738564, 738568, 738569, 738571 thru 738580, 738585 thru 738637, 738639 thru 738676, 738678, 738679, 738681, 738689 thru 738706, 738708, 738709, 738714 thru 738716, 738719 thru 738724, 738726 thru 738729, 738731 thru 738735, 738738 thru 738741, 738745, 738749 thru 738764, 738766, 738767, 738768,738770, 738773, 738775 thru 738781, 738785 thru 738787, 738790 thru 738792, 738794 thru 738835, 738837 thru 738839, 738841 thru 738860, 738862 thru 738922, 738924 thru 738974, 738976 thru 739022, 739024, 739025, 739027 thru 739059, 739061 thru 739063, 739066 thru 739085, 739087, 739089 thru 739096, 739101 thru 739131, 739133 thru 739173, 739175 thru 739392, 739394 thru 739397, 739399 thru 739402, 739404, 739412, 739413, 739415, 739416, 739420, 739421, 739424 thru 739426, 739433, 739434, 739436, 739438, 739439, 739443, 739444, 739451, 739453 thru 739456, 739460, 739464, 739469, 739472, 739477 thru 739489, 739491, 739492, 739494, 739495, 739497, 739498, 739501 thru 739509, 739511 thru 739514, 739517 thru 739521, 739523 thru 739526, 739537 thru 739546, 739548 thru 739557, 739565 thru 739576, 739581, 739584, 739593 thru 739598, 739601 thru 739604, 739611 thru 739616, 739618 thru 739620, 739622 thru 739651, 739654, 739657 thru 739664, 739666 thru 739674, 739676, 739677, 739679 thru 739681, 739684 thru 739692, 739697 thru 739712, 739721 thru 739725, 739729 thru 739738, 739740 thru 739748, 739757, 739758, 739764 thru 739769, 739774 thru 739776, 739797, 739798, 739800 thru 739807, 739809 thru 739816, 739821 thru 739823, 739831 thru 739835, 739837 thru 739846, 739849 thru 739853, 739857 thru 739863, 739865 thru 739872, 739876 thru 739887, 739889 thru 739904, 739907 thru 739916, 739921 thru 739924, 739929,739932 thru 739969, 739971, 739973, 739981 thru 739985, 739992, 739993, 739995 thru 739998, 740000, 740005 thru 740010, 740012, 740017 thru 740019, 740023 thru 740028, 740031 thru 740034, 740036 thru 740038, 740040 thru 740045, 740050 thru 740059, 740065, 740066, 740068, 740070, 740075, 740076, 740079 thru 740088, 740090, 740095, 740096, 740099 thru 740105, 740107 thru 740112, 740115 thru 740131, 740133, 740137 thru 740162, 740166 thru 740176, 740178 thru 740184, 740189 thru 740213, 740215, 740216, 740661 thru 740785, 740787 thru 740870, 740872 thru 740959,740961 thru 741079, 741081 thru 741154, 741156 thru 741185, 741187 thru 741350, 741352 thru 741387, 741389 thru 741469, 741471 thru 741738, 741741 thru 741787, 741789 thru 741792, 741797 thru 741804, 741809 thru 741839, 741845, 741853 thru 741855, 741857 thru 741863, 741865 thru 741876, 741879, 741880, 741882 thru 741886, 741888, thru 741904, 741908, 741909, 741911 thru 741922, 741929 thru 741932, 741939 thru 741944,741949, 741953 thru 741957, 741960, 741961, 741968, 741973 thru 741976, 741981, 741982, 741985, 741986, 741990 thru 741992, 741995, 741996, 742007 thru 742011, 742013 thru 742017, 742020, 742025 thru 742029, 742039, 742040, 742042 thru 742046, 742049 thru, 742051, 742053, 742055 thru 742057, 742059 thru 742061, 742063 thru 742079, 742085 thru 742087, 742089 thru 742091, 742094 thru 742096, 742098 thru 742104, 742109, 742110, 742113 thru 742119, 742125 thru 742144, 742149 thru 742156, 742161, 742162, 742167, 742168, 742171, 742176 thru 742180, 742211 thru 742213, 742233 thru 742236, 742247, 742248,742288 thru 742293, 742297 thru 742300, 742302 thru 742304, 742313 thru 742320, 742325, 742326, 742330, 742341, 742355, 742356, 742365, 742366, 742369, 742372, 742397, 742407 thru 742414, 742423, 742424, 742429 thru 742432, 742439, 742440, 742445, 742446, 742457 thru 742459, 742472, 742501 thru 742503, 742505, 742511, 742512, 742519, 742520, 742529 thru 742532, 742539, 742543, 742546 thru 742548, 742553 thru 742560, 742565, 742569, 742572, 742578 thru 742580, 742585 thru 742588, 742592 thru 742596, 742609 thru 742612, 742615, 742616, 742771, 742783, 742788 thru 742792, 742797, 742813 thru 742815, 742817 thru 742820, 742833, 742836, 742839, 742841, 742855, 742857 thru 742860, 742868, 742883, 742893, 742894, 742898, 742900, 742902 thru 742904, 742911, 742912, 742932, 742935 thru 742937, 742953 thru 742955, 742962, 742963, 742974, 742975, 742977 thru 742979, 742984 thru 742986, 742989, 742995, 743002 thru 743004, 743009, 743020, 743021, 743025 thru 743028, 743073, 743075, 743076, 743078, 743090 thru 743093, 743097, 743100, 743101, 743117 thru 743120, 743126, 743127, 743131 thru 743141, 743146 thru 743149, 743152, 743154, 743164, 743169 thru 743171, 743179, 743182 thru 743185, 743190 thru 743192, 743211, 743212, 743214, 743217, 743218, 743229 thru 743231, 743233, 743242 thru 743244, 743249 thru 743252, 743262, 743263, 743269, 743276 thru 743278, 743280, 743282, 743283, 743303 thru 743308, 743313 thru 743316, 743324 thru 743326, 743345, 743346, 743349 thru 743351, 743358, 743359, 743361 thru 743364, 743369 thru 743376, 743381 thru 743384, 743387 thru 743390, 743393, 743394, 743397, 743398, 743427, 743633, 743821 thru 743824,743876 thru 743878, 743886, 743923, 743924, 743931 thru 743934, 743945, 743946, 743948, 743949, 743958, 744145, 744153 thru 744155, 744165 thru 744168, 744173 thru 744180,744185 thru 744187, 744193, 744212 thru 744222, 744225 thru 744236, 744239 thru 744243, 744249 thru 744252, 744267 thru 744270, 744277 thru 744280, 744289 thru 744293, 744297 thru 744303, 744305, 744306, 744309 thru 744312, 744355, 744369 thru 744372, 744377 thru 744380, 744393, 744396, 744407, 744450 thru 744456, 744461 thru 744464, 744473, 744476, 744524, 744537 thru 744540, 744556, 744562, 744570,744572, 744577 thru 744584, 744596 thru 744598, 744608 thru 744611, 744613, 744614, 744621 thru 744626, 744628, 744633 thru 744636, 744645 thru 744648, 744650 thru 744655, 744657 thru 744660, 744669, 744670, 744680, 744684, 744693 thru 744704, 744706 thru 744708, 744710 thru 744733, 744735, 744736, 744738 thru 744750, 744752 thru 744867, 744869, 744870, 744872 thru, 744878, 744880, 744881, 744884 thru 744991, 744996 thru 745006, 745009 thru 745015, 745018 thru 745020, 745022 thru 745032, 745037 thru 745052, 745054 thru 745056, 745061, 745062, 745066, 745068, 745069, 745073 thru 745084, 745087, 745088, 745090 thru 745093, 745096, 745100 thru 745103, 745105 thru 745187, 745189 thru 745259, 745262 thru 745271, 745274, 745277 thru 745279, 745281 thru 745332, 745334 thru 745397, 745399, 745400, 745402 thru 745611, 745613 thru 745645, 745650, 745654 thru 745662, 745664, 745665, 745667 thru 745674, 745677, 745680 thru 745683, 745685, 745689 thru 745696, 745698 thru 745730, 745735, 745737 thru 745743, 745745, 745753 thru 745875, 745877 thru 745941, 745943 thru 745968, 745970 thru 746002, 746005 thru 746109, 746111 thru 746145, 746147 thru 746156, 746158 thru 746273, 746275, 746276, 746278 thru 746284, 746286 thru 746292, 746294 thru 746411, 746413 thru 746419, 746421 thru 746427, 746429 thru 746456, 746460 thru 746465, 746467, 746469, 746471, 746472, 746477, 746479, 746481 thru 746489, 746491, 746492, 746494 thru 746595, 746597 thru 746726, 746728 thru 746731, 746733 thru 746749, 746751 thru 746820, 746822 thru 746836, 746838 thru 746849, 746851 thru 746854, 746856 thru 746966, 746968 thru 746986, 746988 thru 747035, 747037 thru 747046, 747048 thru 747084, 747086 thru 747100, 747102, 747104 thru 747108, 747110, 747113 thru 747238, 747240 thru 747255, 747257 thru 747261, 747263, 747264, 747266 thru 747288, 747291, 747292, 747294 thru 747369, 747371 thru 747382, 747384 thru 747414, 747416 thru 747418, 747420 thru 747434, 747436 thru 747454, 747456 thru 747458, 747460 thru 747479, 747481 thru 747630, 747632 thru 747664, 747666 thru 747756, 747758 thru 747837, 747839 thru 747879, 747881 thru 747885, 747887 thru 747893, 747895 thru 747916,747918 thru 747963, 747965 thru 747974, 747976 thru 747996, 747998 thru 748021, 748023 thru 748136, 748138 thru 748165, 748167 thru 748173, 748175 thru 748190, 748192 thru 748259, 748261 thru 748263, 748265 thru 748448, 748450 thru 748475, 748477 thru 748509, 748512 thru 748516, 748518 thru 748520, 748522 thru 748555, 748557 thru 748561, 748563 thru 748588, 748590 thru 748628, 748630 thru 748656, 748658, 748661, 748662, 748665, 748666, 748669 thru 748736, 748738 thru 748806, 748808, 748809, 748811 thru 748813, 748820, 748821,748823 thru 748828, 748830, 748831, 748833, 748834, 748836 thru 748839, 748841 thru 748843, 748847, 748849 thru 748862, 748866 thru 748874, 748876 thru 748881, 748883 thru 748933, 748935 thru 748941, 748944 thru 748956, 748959 thru 748961, 748963, 748965 thru 749063, 749065 thru 749150, 749152 thru 749469, 749471 thru 749492, 749494 thru 749499, 749501 thru 749507, 749509 thru 749692, 749694 thru 749696, 749698 thru 749727, 749729 thru 749781, 749783 thru 749818, 749820 thru 750007, 750009 thru 750053, 750055 thru 750396, 750398 thru 750401, 750403 thru 750415, 750417 thru 750706,750708 thru 750752, 750754 thru 750770, 750772 thru 750826, 750828 thru 750907, 750909 thru 750949, 750951 thru 750963, 750965 thru 751078, 751080 thru 751099, 751101 thru 751103, 751105 thru 751112, 751114 thru 751166, 751168, 751169, 751171 thru 751195, 751197 thru 751263, 751265 thru 751279, 751281 thru 751314,751316 thru 751408, 751411, 751413 thru, 751419, 751421, 751422, 751424 thru 751434, 751436 thru 751439, 751441 thru 751445, 751449 thru 751451, 751454, 751464, 751465, 751467, 751469, 751473 thru 751487, 751490, 751494, 751497 thru 751503, 751505, 751509 thru 751535, 751538 thru 751544, 751558, 751561,751564, 751567, 751579, 751608, 751613, 751619, 751620, 751625, 751626, 751629, 751634, 751635, 751639, 751640, 751682, 751686, 751695, 751696, 751701, 751702, 751705, 751706, 751710 thru 751714, 751718 thru 751721, 751724, 751728, 751729, 751734, 751735, 751740, 751741, 751743, 751744, 751757 thru 751760, 751836, 751843, 751845, 751846, 751849, 751859, 751860, 751865, 751874, 751878, 751917, 751925, 752120, 752121, 752129 thru 752131, 752228, 752230 thru 752232, 752239, 752240, 898701.   model 1291, serial numbers: 118042 thru 118054, 118059, 118061, 118063, 118064, 118239, 118244, 118245, 118247, 118249, 118254, 118257, 118258, 118265, 118266, 118270, 118274 thru 118276, 118279, 118281, 118283, 118290 thru 118342, 118344 thru 118359, 118362 thru 118386, 118388, 118390, 118391, 118396 thru 118401, 118403 thru 118408, 118410, 118411, 118416, 118419 thru 118422, 118424 thru 118427, 118429 thru 118441, 118443, 118444, 118446, 118458, 118467 thru 118471, 118473, 118482 thru 118505, 118507 thru 118515, 118517 thru 118523, 118527 thru 118548, 118550 thru 118567, 118569, 118571 thru 118575, 118577, 118580, 118582 thru 118606, 118608 thru 118649, 118651 thru 118689, 118691 thru 118698, 118700 thru 118703, 118705, 118706, 118709, 118710, 118712 thru 118814, 118816 thru 118818, 118820 thru 118950, 118952 thru 118980, 118982 thru 119014, 119016 thru 119022, 119024, 119026, 119028, 119030 thru 119033, 119035, 119036, 119038, 119040 thru 119046, 119053, 119056 thru 119088, 119090 thru 119102, 119105 thru 119155, 119157 thru 119173, 119175 thru 119194, 119197 thru 119220, 119222 thru 119227, 119229 thru 119239, 119243 thru 119302, 119316, 119317, 119320 thru 119322, 119324 thru 119326, 119331 thru 119334, 119336, 119344 thru 119346, 119350, 119353 thru, 119440, 119442 thru 119527, 119529 thru 119611, 119613 thru 119661, 119663 thru 119672, 119674 thru 119719, 119721 thru 119744, 119747 thru 119752, 119754 thru 119775, 119777 thru 119786, 119788 thru 119824, 119826 thru 119892, 119912, 119913, 119918 thru 119924, 119933 thru 119942, 119947, 119948, 119950, 119952, 119958 thru 119961, 119963 thru 119965, 119970, 119971, 119983 thru 119985, 119987 thru 119992, 120003 thru 120005, 120007, 120009, thru 120016, 120019 thru 120021, 120023, 120024, 120030, 120031, 120036, 120039, 120049 thru 120058, 120067, 120151, 120153, 120154, 120173, 120203, 120220 thru 120222, 120243, 120244, 120251, 120252, 120274, 120276, 120277, 120279 thru 120281, 120293 thru 120298, 120339 thru 120341, 120343 thru 120345, 120350, 120361 thru 120364, 120385, 120386, 120405, 120406, 120410, 120415 thru 120418, 120420, 120445, 120446, 120461 thru 120466, 120474 thru 120478, 121191 thru 121194, 121203 thru 121206, 121215 thru 121219, 121222 thru 121228, 121231 thru 121326, 121328, 121330, 121333 thru 121340, 121343 thru 121399, 121401 thru 121410, 121412 thru 121415, 121417 thru 121560, 121562 thru 121569, 121571 thru 121573, 121579 thru 121606, 121608 thru 121612, 121615, 121619 thru 121638, 121640 thru 121652, 121658, 121661 thru 121669, 121671 thru 121738, 121740 thru 121759, 121761 thru 121770, 121772 thru 121782, 121808 thru 121836, 121838 thru 121921, 121923 thru 122004, 122006 thru 122016, 122018 thru 122085, 122087, 122089 thru 122132, 122134 thru 122208, 122210 thru 122252, 122254 thru 122268, 122270 thru 122275, 122277, 122279, thru 122286, 122288 thru 122304, 122306 thru 122346, 122348 thru 122359, 122361 thru 122498, 122500 thru 122545, 122547 thru 122588, 122590 thru 122696, 122698 thru 122741, 122743 thru 122786, 122788 thru 122839, 122841 thru, 122961, 122963 thru 123048, 123050 thru 123183, 123185 thru 123402, 123404 thru 123453, 123455 thru 123457, 123459 thru 123464, 123466 thru 123630, 123632 thru 123662, 123664 thru 123683, 123685 thru 123717, 123720 thru 123777, 123779 thru 123790, 123792 thru 123817, 123819, 123822 thru 123830, 123832 thru 123848, 123850, 123851, 123855 thru 123861, 123863, 123911, 123914, 123917, 123920, 123922 thru 123924, 123926 thru 123929, 123934, 123938 thru, 123941, 123943 thru 123947, 123950 thru 123953, 123957 thru 123959, 123962 thru 123965, 123968, 123969, 124066, 124067, 124075, 124076, 124090, 124091, 124099, 898702.   model 1390, serial numbers: 100275, 100276, 100278 thru 100288, 100290, 100291, 100295 thru 100302, 100304,  100305, 100306, 100315 thru 100331.   model 1490, serial numbers: 100278, 100280, 100281, 100284 thru 100293, 100296 thru 100319, 100321 thru 100343.   model 1491, serial numbers: 100175 thru 100186, 100188, 100189, 100195 thru 100223, 100225 thru 100242.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide- USA and Antigua Barbuda, Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guam, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Micronesia, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela
  • Product Description
    Guidant INSIGNIA I Ultra --family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The Intermedics NEXUS I Ultra (models 1390, 1490, 1491) are not available in the US. The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant.--The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Quantities Distributed by model are as follows: INSIGNIA ULTRA SR model 1190 = 4,590; DR model 1290 = 9,654, model 1291 = 4,038. NEXUS ULTRA SR model 1390 = 15; DR model 1490 = 52, model 1491 = 57.
  • Manufacturer
    Boston Scientific CRM Corp