Devices

INSIGNIA Plus and NEXUS Plus

  • 모델명 / 제조번호(시리얼번호)
    All serial numbers
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    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
  • 제품 설명
    Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) and DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus 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. 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 Plus 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

제조사

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

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Device Recall INSIGNIA Plus and NEXUS Plus
  • 모델명 / 제조번호(시리얼번호)
    model 1194, serial numbers: 138440 thru 138476, 138478 thru 138480, 138482 thru 138607, 138609 thru 138615, 138617 thru 138619, 138628, 138630, 138631, 138636 thru 138640, 138642, 138644 thru 138659, 138662 thru 138666, 138668, 138670 thru 138680, 138682 thru 138684, 138686, 138688 thru 138691, 138693 thru 138700, 138703 thru 138705, 138709, 138710, 138712, 138716, 138717, 138720 thru 138725, 138728 thru 138736, 138738 thru 138742, 138744 thru 138755, 138764 thru 138771, 138784 thru 138786, 138789 thru 138793, 138795, 138799, 138801 thru 138803, 138810 thru 138813, 138815 thru 138826, 138833, 138840 thru 138854, 138858, 138859, 138861 thru 138871, 138873 thru 138879, 138882 thru 138888, 138893, 138894, 138899, 138907 thru 138926, 138928 thru 138932, 138935, 138937 thru 138941, 138946 thru 138948, 138952 thru 138954, 138956 thru 138967, 138969 thru 138980, 138985, 138987, 138992, 138995, 138998, 139001, 139004, 139008 thru 139012, 139014, 139016, 139018, 139019, 139021, 139022, 139027, 139032 thru 139034, 139036, 139037, 139039, 139040, 139042 thru 139045, 139144 thru 139393, 139397 thru 139401, 139404 thru 139406, 139413 thru 139416, 139424, 139425, 139436 thru 139441, 139449, 139450, 139452 thru 139454, 139457 thru 139463, 139465, 139468, 139470, 139473, 139480, 139543 thru 139545, 139560 thru 139562, 139565, 139574, 139579 thru 139583, 139595, 139598 thru 139601, 139609, 139613 thru 139615, 139620, 139621, 139639, 139652, 139653, 139662, 139704 thru 139707, 139732 thru 139734, 139742, 139744, 139745, 139754, 139758 thru 139764, 139766 thru 139768, 139774, 139777, 139806, 139828, 139829, 139834, 139835, 139837 thru 139899, 139901 thru 139918, 139921 thru 139937, 139939, 139943, 139945 thru 139962, 139964 thru 140014, 140016 thru 140034, 140039 thru 140101, 140103 thru 140112, 140114, 140118 thru 140145, 140147 thru 140203, 140205 thru 140241, 140244 thru 140260, 140262 thru 140326, 140328 thru 140353, 140355, 140356, 140358 thru 140389, 140391 thru 140394, 140398, 140403, 140405, 140406, 140408 thru 140565, 140567 thru 140616, 140618 thru 140669, 140671 thru 140742,140744 thru 140756, 140758 thru 40789, 140791 thru 140810, 140813, 140814, 140822, 140823, 140825 thru 140827, 140830, 140839 thru 140842, 141008, 141010.   model 1297, serial numbers: 309128 thru 309131, 309137, 309139, 309142 thru 309147, 309149, 309152 thru 309157, 309160, 309165, 309166, 309169, 309171, 309174, 309180, 309188 thru 309190, 309192 thru 309204, 309208 thru 309211, 309215, 309219 thru 309223, 309226 thru 309245, 309253 thru 309259, 309264 thru 309271, 309273, 309274, 309276 thru 309280, 309283 thru 309290, 309292 thru 309294, 309297, 309300, 309301, 309303 thru 309305, 309308, 309309, 309312 thru 309315, 309317 thru 309320, 309322 thru 309326, 309331, 309335, 309336, 309343, 309352 thru 309359, 309361, 309362, 309364 thru 309367, 309372 thru 309375, 309377 thru 309382, 309386, 309387, 309390 thru 309393, 309396, 309397, 309401 thru 309528, 309530 thru 309637, 309639 thru 309648, 309650 thru 309740, 309742 thru 309825, 309829 thru 309937, 310033, 310036 thru 310052, 310054, 310057 thru 310060, 310074 thru 310085, 310087 thru 310090, 310092 thru 310096, 310098 thru 310100, 310103 thru 310106, 310109 thru 310130, 310132 thru 310223, 310230 thru 310249, 310251 thru 310302, 310304 thru 310345, 310348 thru 310366, 310368 thru 310447, 310449 thru 310505, 310507 thru 310546, 310548 thru 310699, 310701 thru 310752, 310754 thru 310760, 310763, 310766 thru 310781, 310783, 310788 thru 310791, 310799 thru 310804, 310807 thru 310809, 310812 thru 310817, 310819 thru 310908, 310910 thru 310914, 310916 thru 311050, 311052 thru 311066, 311068 thru 311084, 311086 thru 311130, 311135, 311136, 311141 thru 311143, 311146, 311147, 311152, 311158 thru 311160, 311163, 311167 thru 311171, 311176 thru 311184, 311186, 311187.   model 1298, serial numbers: 217565, 217643, 217645, 217697, 217698, 217754 thru 217756, 217758, 217762 thru 217766, 217768, 217771, 217772, 217774, 217775, 217777 thru 217789, 217791 thru 217795, 217797, 217798, 217800 thru 217808, 217810 thru 217813, 217815 thru 217817, 217819 thru 217832, 217834 thru 217922, 217924 thru, 217952, 217954 thru 217992, 217994, 217995, 218003, 218004, 218019, 218020, 218022 thru 218024, 218026 thru 218037, 218040, 218042 thru 218048, 218050, 218051, 218053 thru 218056, 218058 thru 218061, 218065, 218068, 218072 thru 218077, 218080, 218081, 218086 thru 218089, 218091 thru 218094, 218096, 218097, 218099, 218101, 218103, 218105, 218106, 218108 thru 218111, 218114, 218115, 218118, 218120, 218122, 218123, 218125 thru 218130, 218132 thru 218143, 218153 thru 218160, 218165 thru 218172, 218177 thru 218180, 218190 thru 218192, 218194, 218198, 218199, 218201, 218202, 218212, 218213, 218217, 218218, 218223 thru 218225, 218227 thru 218235, 218238, 218239, 218242 thru 218245, 218248 thru 218253, 218255, 218258 thru 218264, 218266, 218268, 218271 thru 218278, 218283 thru 218285, 218289 thru 218292, 218301 thru 218304, 218307 thru 218309, 218313 thru 218316, 218321, 218322, 218324 thru 218327, 218329, 218333 thru 218336, 218338 thru 218340, 218342, 218343, 218345 thru 218360, 218365 thru 218372, 218377 thru 218384, 218389 thru 218396, 218398, 218399,218401 thru 218408, 218410, 218413 thru 218415, 218430, 218441, 218443, 218444, 218449 thru 218452, 218457, 218461 thru 218463, 218465 thru 218467, 218469 thru 218475, 218477 thru 218480, 218483, 218485, 218486, 218490, 218495 thru 218497, 218499, 218502 thru 218504, 218506 thru 218512, 218517 thru 218526, 218530 thru 218532, 218534, 218535, 218537, 218538, 218540, 218843 thru 218875, 218877 thru 218909, 218911 thru 218936, 218938 thru 219000, 219002 thru 219061, 219063 thru 219210, 219212, 219214 thru 219345, 219347 thru 219470, 219491 thru 219494, 219500 thru 219505, 219519, 219526 thru 219528, 219534 thru 219545, 219548, 219549, 219551, 219566 thru 219569, 219594 thru 219597, 219599, 219600, 219611 thru 219614, 219623 thru 219625, 219628 thru 219630, 219634, 219635, 219638, 219669, 219684,219692 thru 219694, 219731 thru 219734, 219755, 219763 thru 219766, 219781, 219782, 219832, 219841, 219844, 219848, 219849, 219851, 219853, 219854,219863 thru 219865, 219874, 219875, 219882, 219883, 219885,219887 thru 219889, 219927, 219934, 219938, 219953, 219963,219973 thru 219976, 219979 thru 219982, 219991, 219992, 220001, 220002, 220007, 220008, 220011, 220012, 220017, 220019, 220028, 220041 thru 220044, 220049, 220050, 220052 thru 220054, 220072, 220075, 220081, 220083, 220085, 220188, 220198, thru 220201, 220212, 220213, 220218 thru 220221, 220229, 220235 thru 220238, 220259, 220260, 220271, 220272, 220287 thru 220289, 220299 thru 220306, 220314, 220315, 220317, 220318, 220325 thru 220328, 220332, 220336 thru 220346, 220353, 220356, 220369, 220372 thru 220374, 220379, 220380, 220382 thru 220389, 220391, 220392, 220395 thru 220457, 220459 thru 220534, 220538 thru 220550, 220556, 220557, 220560, 220563 thru 220573, 220575 thru 220578, 220584, 220587 thru 220591, 220593 thru 220630, 220632 thru 220725, 220728, 220731, 220733, 220735 thru 220737, 220739, 220740, 220744, 220747 thru 220749, 220751, 220752, 220755, 220756, 220758 thru 220770, 220774 thru 221034, 221036 thru 221049, 221051 thru 221071, 221073 thru, 221108, 221110 thru 221144, 221147 thru 221197, 221199 thru 221322, 221327 thru 221340, 221343 thru 221352, 221354 thru 221357, 221359 thru 221372, 221374 thru 221384, 221386 thru 221454, 221456 thru 221493, 221495, 221497 thru 221767, 221769 thru 221879, 221881 thru 221922, 221924, 221925, 221927 thru 221956, 221959, 221960, 221962 thru 222013, 222015 thru 222116, 222118 thru 222121, 222123 thru 222154, 222156 thru 222162, 222164 thru 222199, 222201 thru 222235, 222237 thru 222264, 222266 thru 222287, 222289 thru 222373, 222375 thru 222377, 222380 thru 222383, 222385 thru 222388, 222391, 222393, 222398, 222399, 222401, 222402, 222404 thru 222412, 222426,222458, 222465, 222469, 222470, 222472, 222476, 222548, 222549, 222559, 222567, 222568.   model 1467, serial numbers: 103050 thru 103059, 103061 thru 103069, 103071 thru 103090, 103092 thru 103148, 103151, 103152, 103155 thru 103157, 103159, 103160, 103162 thru 103190, 103192 thru 103201, 103208, 103209, 103214, 103218, 103226 thru 103232, 103234, 103238, 103240, 103241, 103244 thru 103248, 103250 thru 103253, 103309 thru 103313, 103323 thru 103328, 103346 thru 103349, 103352, 103353, 103373, 103374, 103379 thru 103381, 103385, 103388, 103389, 103406 thru 103474, 103476 thru 103480, 103483 thru 103489, 103491 thru 103527, 103530 thru 103565, 103567 thru 103569, 103571 thru 103575, 103577, 103578, 103580, 103581, 103586 thru 103595, 103598 thru 103660, 103662 thru 103725, 103732 thru 103737.   model 1468, serial numbers: 107133, 107134, 107136 thru 107147, 107150 thru 107299, 107301 thru 107325, 107327, 107328, 107330 thru 107337, 107340 thru 107342, 107344 thru 107353, 107378 thru 107405, 107407 thru 107413, 107415 thru 107425, 107430 thru 107437, 107442 thru 107444, 107447 thru 107449, 107455 thru 107457, 107467 thru 107469, 107478 thru 107481, 107490 thru 107493, 107498 thru 107500, 107503 thru 107505, 107510, thru 107518, 107520 thru 107528, 107530 thru 107569, 107571 thru 107576, 107578 thru 107581, 107586 thru 107593, 107595 thru 107668, 107671 thru 107693, 107695 thru 107721, 107724 thru 107726, 107729, 107820, 107821, 107823, 107947 thru 107949, 107952, 107955, 107961 thru 107964, 107966, 107969, 107971 thru 107977, 107989, 108006, 108010, 108012 thru 108018, 108027, 108029 thru 108031, 108037 thru 108044, 108051 thru 108105, 108110 thru 108160, 108162 thru 108181, 108183 thru 108198, 108200 thru 108212, 108214, 108216 thru 108227, 108229 thru 108282, 108284 thru 108350, 108355 thru 108402, 108404 thru 108458, 108460 thru 108467, 108469 thru 108547, 108549 thru 108672, 108674 thru 108709, 108720 thru 108724, 108861, 108862, 108868, 108872, 108877, 108894.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    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
  • 제품 설명
    Guidant INSIGNIA I Plus --family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. --The NEXUS I Plus 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 PLUS SR model 1194 = 1,587; DR model 1297 = 1,710, model 1298 = 3,117. NEXUS PLUS SR model 1394 = 517; DR model 1467 = 490, 1468 = 1,107.
  • Manufacturer
    Boston Scientific CRM Corp