Device Recall VITALITY 2 EL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific CRM Corp 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    37769
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1055-2007
  • 사례 시작날짜
    2007-03-23
  • 사례 출판 날짜
    2007-07-11
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2008-03-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    implantable defibrillator - Product Code NIK
  • 원인
    Boston scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. these capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (eri) and end of life (eol) to less than 3 months.
  • 조치
    An Urgent Medical Devivce Information letter dated April 05, 2007 was sent to implanting and following physicians. The letter describes the issue, identifies patients with affected devices and provides recommendations.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model T167, serial numbers: 101193, 101196, 101238, 101239, 101240, 101241, 101258, 101259, 101261, 101262, 101263, 101264, 101265, 101266, 101267, 101268, 101269, 101270, 101271, 101272, 101273, 101274, 101275, 101276, 101277, 101278, 101279, 101280, 101281, 101284, 101286, 101287, 101288, 101289, 101291, 101292, 101293, 101294, 101296, 101297, 101298, 101299, 101300, 101301, 101313, 101315, 101316, 101319, 101321, 101353, 101354, 101356, 101367, 101368, 101370, 101372, 101373, 101374, 101375, 101376, 101377, 101378, 101379, 101388, 101389, 101390, 101391, 101393, 101394, 101395, 101396, 101398, 101400, 101401, 101406, 101440, 101443, 101446, 101448, 101449, 101450, 101451, 101456, 101457, 101462, 101464, 101465, 101466, 101472, 101474, 101475, 101476, 101479, 101480, 101488, 101489, 101499, 101500, 101501, 101502, 101503, 101504, 101507, 101509, 101510, 101511, 101513, 101514, 101542, 101544, 101545, 101547, 101549, 101550, 101567, 101568, 101569, 101570, 101571, 101575, 101577, 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104451, 104452, 104455, 104456, 104457, 104458, 104459, 104460, 104463, 104464, 104465, 104466, 104467, 104469, 104470, 104471, 104473, 104474, 104475, 104476, 104477, 104479, 104480, 104481, 104482, 104483, 104484, 104485, 104486, 104489, 104491, 104492, 104493, 104495, 104498, 104499, 104500, 104501, 104503, 104504, 104505, 104506, 104507, 104509, 104510, 104511, 104512, 104513, 104514, 104515, 104516, 104517, 104518, 104519, 104520, 104521, 104522, 104523, 104524, 104525, 104526, 104527, 104528, 104529, 104530, 104531, 104532, 104533, 104534, 104535, 104536, 104537, 104538, 104539, 104540, 104541, 104542, 104543, 104544, 104545, 104546, 104547, 104548, 104549, 104550, 104551, 104552, 104553, 104555, 104557, 104558, 104559, 104560, 104561, 104562, 104563, 104564, 104566, 104567, 104568, 104569, 104570, 104571, 104573, 104574, 104575, 104576, 104577, 104578, 104579, 104580, 104581, 104582, 104584, 104585, 104587, 104588, 104590, 104592, 104593, 104594, 104595, 104597, 104598, 104599, 104600, 104601, 104602, 104603, 104604, 104605, 104606, 104607, 104608, 104609, 104610, 104612, 104613, 104614, 104615, 104616, 104617, 104618, 104619, 104620, 104621, 104622, 104623, 104624, 104625, 104626, 104629, 104630, 104631, 104632, 104633, 104634, 104635, 104636, 104637, 104638, 104639, 104641, 104642, 104643, 104644, 104646, 104647, 104648, 104649, 104650, 104651, 104652, 104653, 104654, 104656, 104658, 104659, 104660, 104661, 104662, 104663, 104664, 104665, 104666, 104667, 104669, 104670, 104671, 104673, 104674, 104675, 104676, 104677, 104678, 104679, 104680, 104681, 104683, 104686, 104687, 104688, 104689, 104690, 104691, 104692, 104694, 104695, 104696, 104697, 104698, 104699, 104702, 104703, 104705, 104706, 104707, 104708, 104709, 104710, 104711, 104712, 104713, 104714, 104715, 104716, 104717, 104718, 104719, 104720, 104721, 104722, 104724, 104725, 104726, 104728, 104729, 104730, 104731, 104733, 104734, 104735, 104736, 104737, 104739, 104740, 104741, 104742, 104743, 104744, 104745, 104746, 104747, 104748, 104749, 104750, 104751, 104752, 104753, 104754, 104755, 104756, 104757, 104758, 104759, 104760, 104761, 104762, 104763, 104764, 104765, 104766, 104768, 104769, 104770, 104771, 104772, 104773, 104774, 104775, 104776, 104777, 104778, 104780, 104781, 104782, 104783, 104784, 104786, 104787, 104792, 104793, 104794, 104795, 104797, 104798, 104800, 104802, 104803, 104805, 104806, 104809, 104810, 104811, 104812, 104813, 104814, 104815, 104816, 104817, 104818, 104819, 104820, 104822, 104823, 104824, 104826, 104827, 104828, 104829, 104830, 104831, 104832, 104834, 104835, 104836, 104837, 104838, 104840, 104841, 104842, 104844, 104845, 104846, 104847, 104848, 104849, 104851, 104853, 104854, 104855, 104856, 104857, 104858, 104859, 104860, 104861, 104862, 104864, 104865, 104866, 104867, 104868, 104869, 104870, 104871, 104872, 104873, 104874, 104876, 104877, 104878, 104879, 104880, 104881, 104882, 104883, 104884, 104885, 104886, 104887, 104888, 104890, 104891, 104892, 104894, 104895, 104896, 104897, 104898, 104899, 104901, 104902, 104905, 104907, 104908, 104909, 104910, 104911, 104912, 104913, 104914, 104915, 104916, 104917, 104918, 104919, 104920, 104921, 104922, 104923, 104924, 104925, 104926, 104927, 104928, 104929, 104930, 104931, 104932, 104934, 104937, 104938, 104939, 104940, 104941, 104942, 104943, 104944, 104945, 104946, 104947, 104948, 104949, 104951, 104952, 104953, 104954, 104955, 104956, 104957, 104958, 104959, 104960, 104961, 104962, 104963, 104964, 104965, 104966, 104967, 104968, 104969, 104970, 104971, 104972, 104973, 104974, 104975, 104976, 104977, 104978, 104979, 104980, 104981, 104982, 104983, 104984, 104985, 104986, 104987, 104988, 104989, 104990, 104992, 104993, 104994, 104995, 104996, 104997, 104998, 104999, 105000, 105001, 105002, 105003, 105005, 105006, 105007, 105008, 105010, 105012, 105014, 105016, 105017, 105018, 105020, 105022, 105023, 105024, 105025, 105026, 105027, 105028, 105029, 105030, 105031, 105032, 105033, 105034, 105035, 105036, 105037, 105038, 105039, 105040, 105041, 105042, 105043, 105044, 105045, 105046, 105047, 105049, 105050, 105051, 105053, 105054, 105056, 105057, 105058, 105059, 105060, 105061, 105062, 105063, 105064, 105066, 105067, 105068, 105069, 105070, 105071, 105072, 105073, 105074, 105075, 105076, 105078, 105079, 105080, 105081, 105082, 105083, 105084, 105085, 105086, 105087, 105088, 105089, 105091, 105092, 105093, 105094, 105095, 105096, 105097, 105098, 105099, 105100, 105101, 105102, 105103, 105106, 105107, 105108, 105109, 105110, 105111, 105115, 105153, 105154, 105155, 105156, 105157, 105158, 105159, 105160, 105161, 105162, 105163, 105164, 105165, 105166, 105167, 105168, 105169, 105170, 105171, 105172, 105174, 105175, 105176, 105177, 105178, 105180, 105181, 105182, 105183, 105184, 105185, 105186, 105188, 105189, 105190, 105191, 105192, 105193, 105194, 105195, 105196, 105198, 105199, 105200, 105201, 105202, 105205, 105206, 105207, 105208, 105209, 105210, 105211, 105212, 105213, 105214, 105215, 105216, 105217, 105218, 105219, 105220, 105221, 105222, 105223, 105224, 105225, 105227, 105228, 105229, 105230, 105231, 105232, 105233, 105237, 105238, 105241, 105244, 105247, 105248, 105250, 105252, 105255, 105256, 105258, 105259, 105260, 105264, 105268, 105269, 105272, 105274, 105276, 105277, 105281, 105283, 105284, 105286, 105287, 105289, 105291, 105292, 105293, 105295, 105296, 105297, 105298, 105299, 105301, 105302, 105304, 105305, 105306, 105308, 105310, 105313, 105314, 105316, 105317, 105321, 105323, 105327, 105328, 105329, 105330, 105335, 105336, 105338, 105341, 105343, 105345, 105346, 105350, 105351, 105353, 105354, 105355, 105357, 105360, 105361, 105362, 105364, 105365, 105366, 105368, 105371, 105372, 105373, 105376, 105377, 105380, 105381, 105382, 105383, 105385, 105387, 105389, 105390, 105392, 105393, 105397, 105398, 105399, 105401, 105410, 105411, 105412, 105413, 105414, 105415, 105416, 105417, 105418, 105419, 105420, 105421, 105422, 105423, 105424, 105425, 105429, 105431, 105432, 105439, 105440, 105441, 105443, 105444, 105450, 105454, 105455, 105456, 105457, 105458, 105459, 105460, 105461, 105464, 105466, 105469, 105470, 105471, 105473, 105474, 105476, 105477, 105478, 105479, 105481, 105482, 105496, 105497, 105501, 105503, 105504, 105506, 105507, 105508, 105509, 105510, 105511, 105512, 105513, 105514, 105515, 105516, 105517, 105518, 105519, 105520, 105521, 105522, 105525, 105526, 105530, 105533, 105534, 105535, 105537, 105538, 105540, 105541, 105542, 105543, 105544, 105547, 105549, 105551, 105553, 105554, 105555, 105556, 105557, 105559, 105561, 105562, 105564, 105565, 105566, 105567, 105568, 105569, 105572, 105573, 105575, 105576, 105577, 105583, 105584, 105585, 105589, 105590, 105591, 105600, 105601, 105613, 105615, 105619, 105622, 105623, 105625, 105633, 105634, 105635, 105636, 105638, 105639, 105655, 105658, 105659, 105662, 105663, 105665, 105668, 105670, 105671, 105678, 105679, 105680, 105681, 105682, 105690, 105694, 105695, 105728, 105751, 105755, 105810, 105813, 105814, 105815, 105816, 105817, 105818, 105819, 105820, 105821, 105822, 105823, 105824, 105825, 105826, 105827, 105828, 105829, 105830, 105831, 105832, 105847, 105848, 105853, 105854, 105855, 105856, 105857, 105858, 105859, 105860, 105861, 105862, 105863, 105864, 105865, 105866, 105869, 105870, 105871, 105872, 105873, 105875, 105876, 105877, 105878, 105879, 105880, 105881, 105882, 105883, 105884, 105885, 105886, 105887, 105888, 105889, 105890, 105891, 105892, 105893, 105894, 105895, 105896, 105897, 105899, 105900, 105902, 105903, 105904, 105905, 105906, 105907, 105908, 105909, 105910, 105911, 105912, 105913, 105914, 105915, 105916, 105917, 105919, 105920, 105921, 105922, 105923, 105924, 105925, 105926, 105927, 105928, 105929, 105930, 105931, 105932, 105933, 105934, 105936, 105938, 105939, 105940, 105941, 105942, 105943, 105944, 105945, 105946, 105947, 105950, 105951, 105952, 105954, 105955, 105956, 105957, 105959, 105960, 105961, 105963, 105965, 105966, 105967, 105968, 105969, 105970, 105971, 105972, 105973, 105974, 105975, 105976, 105977, 105978, 105979, 105980, 105981, 105982, 105983, 105984, 105985, 105986, 105987, 105988, 105989, 105990, 105992, 105993, 105994, 105995, 105996, 105997, 105998, 105999, 106117, 106181, 106230, 106275, 106276, 106343, 106388, 106391, 106400, 106402, 106403, 106405, 106406, 106411, 106433, 106506, 106509, 106571, 106573, 106783, 106784, 106787, 106788, 116756.  Model T177, serial numbers: 101050, 101053, 101068, 101083, 101087, 101089, 101100, 101101, 101102, 101103, 101105, 101106, 101107, 101109, 101110, 101111, 101113, 101114, 101115, 101116, 101117, 101118, 101119, 101120, 101121, 101122, 101123, 101124, 101125, 101127, 101128, 101129, 101130, 101131, 101132, 101133, 101134, 101138, 101147, 101148, 101155, 101166, 101172, 101187, 101219, 101236, 101239, 101290, 101293, 101294, 101296, 101297, 101298, 101299, 101300, 101301, 101303, 101305, 101307, 101308, 101309, 101311, 101312, 101313, 101315, 101318, 101319, 101340, 101343, 101350, 101351, 101352, 101353, 101354, 101356, 101359, 101360, 101361, 101365, 101366, 101367, 101373, 101377, 101453, 101465, 101466, 101467, 101468, 101469, 101472, 101473, 101474, 101475, 101477, 101479, 101481, 101484, 101498, 101499, 101500, 101501, 101505, 101507, 101509, 101510, 101512, 101513, 101514, 101515, 101516, 101517, 101518, 101519, 101546, 101607, 101631, 101700, 101702, 101703, 101709, 101711, 101716, 101717, 101722, 101726, 101728, 101729, 101732, 101733, 101734, 101767, 101768, 101769, 101770, 101854, 101857, 101862, 101863, 101866, 101867, 101868, 101878, 101886, 101887, 101891, 101892, 101893, 101896, 101900, 101901, 101903, 101905, 101906, 101907, 101908, 101909, 101914, 101915, 101916, 101917, 101918, 101920, 101922, 101923, 101924, 101925, 101926, 101927, 101929, 101930, 101932, 101933, 101934, 101938, 101939, 101941, 101942, 101943, 101944, 101945, 101946, 101947, 101969, 101971, 101998, 101999, 102000, 102001, 102002, 102011, 102012, 102013, 102014, 102025, 102031, 102032, 102033, 102034, 102037, 102038, 102041, 102042, 102046, 102049, 102051, 102054, 102056, 102057, 102058, 102059, 102060, 102061, 102063, 102064, 102085, 102086, 102087, 102089, 102091, 102092, 102093, 102094, 102096, 102099, 102100, 102101, 102102, 102103, 102104, 102105, 102106, 102107, 102108, 102109, 102110, 102111, 102112, 102113, 102114, 102115, 102117, 102118, 102119, 102122, 102123, 102124, 102131, 102135, 102154, 102155, 102157, 102159, 102160, 102163, 102165, 102166, 102167, 102168, 102169, 102171, 102172, 102173, 102174, 102175, 102176, 102177, 102178, 102179, 102181, 102182, 102183, 102184, 102185, 102186, 102187, 102188, 102189, 102191, 102196, 102197, 102201, 102203, 102205, 102206, 102207, 102209, 102210, 102211, 102214, 102215, 102216, 102218, 102220, 102222, 102223, 102224, 102225, 102226, 102227, 102230, 102231, 102232, 102233, 102234, 102235, 102236, 102237, 102239, 102240, 102241, 102242, 102243, 102244, 102245, 102246, 102247, 102248, 102251, 102252, 102253, 102254, 102255, 102256, 102258, 102261, 102263, 102264, 102267, 102269, 102271, 102272, 102273, 102274, 102275, 102279, 102281, 102283, 102285, 102286, 102287, 102288, 102289, 102291, 102292, 102294, 102295, 102296, 102297, 102299, 102300, 102301, 102302, 102303, 102308, 102311, 102312, 102317, 102318, 102319, 102320, 102321, 102322, 102323, 102326, 102328, 102329, 102331, 102332, 102333, 102334, 102336, 102338, 102339, 102341, 102342, 102343, 102344, 102345, 102349, 102351, 102355, 102358, 102359, 102360, 102361, 102365, 102373, 102375, 102377, 102378, 102379, 102380, 102382, 102383, 102385, 102387, 102389, 102390, 102391, 102392, 102393, 102394, 102395, 102396, 102397, 102398, 102400, 102401, 102403, 102404, 102405, 102406, 102408, 102409, 102410, 102411, 102412, 102413, 102416, 102418, 102420, 102421, 102422, 102425, 102426, 102427, 102428, 102429, 102457, 102459, 102460, 102462, 102463, 102465, 102467, 102474, 102475, 102478, 102482, 102485, 102486, 102489, 102490, 102491, 102493, 102496, 102497, 102499, 102500, 102501, 102502, 102503, 102505, 102506, 102508, 102509, 102511, 102512, 102513, 102514, 102519, 102524, 102528, 102532, 102537, 102543, 102544, 102546, 102549, 102554, 102575, 102580, 102581, 102582, 102583, 102584, 102585, 102586, 102587, 102588, 102589, 102590, 102591, 102592, 102593, 102595, 102596, 102597, 102598, 102600, 102601, 102602, 102603, 102604, 102605, 102606, 102608, 102622, 102624, 102628, 102630, 102632, 102633, 102638, 102641, 102642, 102643, 102645, 102646, 102648, 102658, 102665, 102666, 102668, 102670, 102671, 102672, 102673, 102674, 102675, 102676, 102677, 102678, 102679, 102680, 102681, 102682, 102683, 102684, 102687, 102689, 102690, 102692, 102693, 102694, 102695, 102696, 102697, 102698, 102699, 102712, 102713, 102714, 102715, 102716, 102717, 102720, 102721, 102723, 102724, 102725, 102726, 102727, 102728, 102729, 102730, 102732, 102733, 102735, 102743, 102751, 102753, 102758, 102767, 102768, 102769, 102770, 102771, 102772, 102775, 102776, 102777, 102778, 102779, 102780, 102781, 102782, 102784, 102800, 102801, 102802, 102803, 102804, 102805, 102807, 102808, 102810, 102813, 102815, 102816, 102817, 102819, 102820, 102821, 102822, 102823, 102825, 102826, 102827, 102828, 102829, 102830, 102831, 102832, 102833, 102834, 102835, 102836, 102840, 102843, 102844, 102846, 102847, 102851, 102852, 102855, 102856, 102858, 102859, 102860, 102861, 102862, 102863, 102864, 102865, 102866, 102867, 102868, 102869, 102870, 102871, 102872, 102873, 102874, 102876, 102877, 102878, 102880, 102882, 102885, 102886, 102890, 102891, 102892, 102894, 102895, 102896, 102899, 102903, 102905, 102906, 102913, 102915, 102937, 102939, 102941, 102942, 102944, 102945, 102947, 102949, 102950, 102951, 102952, 102953, 102954, 102955, 102957, 102959, 102960, 102961, 102962, 102963, 102964, 102965, 102966, 102967, 102968, 102969, 102970, 102971, 102972, 102973, 102974, 102975, 102976, 102982, 102984, 102985, 102990, 102991, 102992, 102993, 102994, 102995, 102997, 103002, 103004, 103008, 103011, 103013, 103015, 103017, 103020, 103021, 103023, 103024, 103026, 103027, 103028, 103029, 103030, 103031, 103032, 103034, 103036, 103037, 103038, 103039, 103040, 103041, 103042, 103043, 103044, 103053, 103058, 103069, 103083, 103088, 103092, 103094, 103098, 103100, 103103, 103104, 103105, 103109, 103110, 103113, 103114, 103115, 103116, 103117, 103119, 103120, 103121, 103122, 103123, 103124, 103125, 103126, 103127, 103128, 103132, 103133, 103134, 103135, 103138, 103139, 103143, 103144, 103145, 103146, 103147, 103148, 103150, 103151, 103152, 103153, 103154, 103155, 103157, 103158, 103160, 103162, 103164, 103174, 103175, 103180, 103181, 103182, 103184, 103186, 103187, 103188, 103189, 103190, 103191, 103194, 103196, 103197, 103198, 103200, 103202, 103204, 103206, 103207, 103211, 103213, 103224, 103229, 103230, 103231, 103232, 103233, 103234, 103239, 103246, 103248, 103261, 103262, 103264, 103265, 103266, 103270, 103272, 103274, 103275, 103276, 103277, 103278, 103279, 103285, 103286, 103290, 103291, 103298, 103302, 103303, 103307, 103309, 103332, 103333, 103334, 103336, 103339, 103340, 103346, 103350, 103351, 103352, 103353, 103354, 103356, 103358, 103365, 103366, 103367, 103371, 103372, 103374, 103375, 103376, 103378, 103392, 103401, 103403, 103406, 103409, 103412, 103414, 103417, 103428, 103429, 103430, 103431, 103433, 103446, 103449, 103455, 103461, 103462, 103464, 103471, 103472, 103474, 103482, 103483, 103485, 103487, 103489, 103492, 103493, 103494, 103496, 103497, 103502, 103525, 103527, 103528, 103529, 103530, 103531, 103532, 103533, 103535, 103536, 103537, 103539, 103540, 103541, 103542, 103543, 103544, 103547, 103549, 103614, 103663, 103666, 103672, 103673, 103675, 103679, 103685, 103687, 103689, 103693, 103695, 103699, 103706, 103709, 103712, 103713, 103715, 103719, 103723, 103727, 103728, 103730, 103731, 103732, 103733, 103735, 103738, 103740, 103741, 103743, 103744, 103745, 103746, 103747, 103750, 103751, 103754, 103755, 103757, 103761, 103764, 103765, 103766, 103768, 103770, 103771, 103772, 103773, 103774, 103775, 103776, 103779, 103781, 103785, 103789, 103791, 103793, 103796, 103798, 103801, 103802, 103804, 103805, 103809, 103810, 103814, 103815, 103816, 103818, 103821, 103823, 103825, 103827, 103828, 103829, 103830, 103832, 103834, 103836, 103838, 103839, 103841, 103845, 103846, 103847, 103849, 103850, 103851, 103852, 103853, 103854, 103855, 103856, 103857, 103858, 103859, 103860, 103861, 103862, 103863, 103865, 103868, 103869, 103870, 103871, 103872, 103876, 103877, 103878, 103879, 103880, 103881, 103882, 103883, 103885, 103886, 103888, 103889, 103890, 103891, 103892, 103895, 103896, 103897, 103899, 103900, 103901, 103904, 103905, 103907, 103909, 103911, 103913, 103916, 103917, 103920, 103923, 103926, 103929, 103930, 103931, 103933, 103935, 103939, 103940, 103942, 103944, 103950, 103951, 103952, 103953, 103954, 103955, 103958, 103959, 103960, 103962, 103964, 103965, 103966, 103967, 103970, 103971, 103975, 103981, 103984, 103987, 104101, 104102, 104103, 104107, 104112, 104114, 104116, 104117, 104118, 104120, 104122, 104123, 104124, 104126, 104127, 104128, 104129, 104130, 104131, 104132, 104134, 104136, 104140, 104141, 104144, 104146, 104147, 104148, 104149, 104150, 104151, 104153, 104154, 104155, 104156, 104157, 104158, 104160, 104161, 104162, 104163, 104164, 104165, 104166, 104167, 104168, 104170, 104171, 104172, 104173, 104174, 104175, 104176, 104177, 104179, 104181, 104182, 104183, 104184, 104186, 104187, 104188, 104189, 104190, 104191, 104192, 104194, 104195, 104196, 104197, 104198, 104199, 104202, 104203, 104204, 104205, 104206, 104207, 104208, 104209, 104210, 104211, 104212, 104213, 104214, 104215, 104216, 104217, 104218, 104219, 104220, 104222, 104223, 104224, 104225, 104226, 104227, 104228, 104229, 104230, 104232, 104233, 104234, 104235, 104238, 104239, 104240, 104241, 104242, 104243, 104249, 104250, 104251, 104252, 104253, 104257, 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104267, 104272, 104273, 104275, 104281, 104283, 104286, 104297, 104302, 104304, 104305, 104306, 104308, 104309, 104311, 104313, 104314, 104315, 104316, 104318, 104320, 104321, 104323, 104324, 104326, 104329, 104333, 104334, 104339, 104341, 104342, 104343, 104344, 104345, 104351, 104355, 104357, 104359, 104360, 104362, 104364, 104366, 104368, 104376, 104379, 104382, 104384, 104385, 104389, 104391, 104393, 104394, 104397, 104398, 104403, 104408, 104409, 104411, 104412, 104415, 104416, 104417, 104418, 104419, 104420, 104421, 104422, 104423, 104424, 104425, 104426, 104427, 104428, 104429, 104430, 104431, 104432, 104433, 104434, 104435, 104436, 104437, 104438, 104439, 104442, 104445, 104448, 104449, 104450, 104451, 104452, 104453, 104454, 104457, 104458, 104461, 104463, 104464, 104466, 104470, 104471, 104472, 104473, 104474, 104476, 104478, 104479, 104482, 104484, 104487, 104488, 104490, 104492, 104494, 104495, 104498, 104501, 104503, 104504, 104505, 104506, 104507, 104509, 104510, 104512, 104513, 104534, 104538, 104539, 104544, 104545, 104547, 104548, 104552, 104553, 104556, 104557, 104558, 104559, 104560, 104561, 104562, 104563, 104564, 104588, 104590, 104591, 104593, 104599, 104603, 104605, 104606, 104607, 104608, 104609, 104612, 104619, 104634, 104641, 104645, 104646, 104653, 104674, 104676, 104680, 104681, 104682, 104683, 104684, 104685, 104686, 104687, 104688, 104689, 104690, 104692, 104693, 104697, 104699, 104702, 104705, 104706, 104709, 104715, 104720, 104724, 104745, 104746, 104750, 104751, 104756, 104757, 104758, 104759, 104761, 104762, 104763, 104764, 104765, 104766, 104767, 104768, 104769, 104770, 104771, 104772, 104773, 104774, 104775, 104776, 104777, 104778, 104780, 104781, 104782, 104783, 104785, 104787, 104788, 104789, 104790, 104791, 104792, 104793, 104795, 104796, 104797, 104798, 104799, 104801, 104803, 104804, 104805, 104806, 104807, 104808, 104809, 104811, 104812, 104813, 104814, 104815, 104816, 104817, 104818, 104819, 104820, 104821, 104822, 104823, 104824, 104825, 104826, 104827, 104828, 104829, 104830, 104831, 104832, 104833, 104834, 104835, 104836, 104837, 104838, 104840, 104844, 104853, 104854, 104856, 104857, 104858, 104859, 104862, 104864, 104867, 104868, 104869, 104871, 104872, 105011, 105012, 105013, 105014, 105015, 105017, 105018, 105020, 105021, 105022, 105023, 105024, 105025, 105026, 105027, 105028, 105029, 105030, 105031, 105032, 105033, 105034, 105035, 105036, 105038, 105039, 105040, 105041, 105042, 105043, 105044, 105045, 105046, 105048, 105049, 105051, 105052, 105054, 105055, 105056, 105057, 105060, 105061, 105062, 105063, 105064, 105065, 105066, 105067, 105068, 105069, 105070, 105071, 105073, 105074, 105075, 105076, 105077, 105078, 105079, 105080, 105081, 105082, 105084, 105085, 105088, 105090, 105091, 105093, 105094, 105096, 105099, 105102, 105105, 105147, 105149, 105176, 105177, 105179, 105183, 105190, 105210, 105219, 105231, 105237, 105238, 105239, 105241, 105242, 105245, 105247, 105248, 105250, 105313, 105367, 105404, 105421, 105497, 105530, 105531, 105576, 105581, 105587, 105589, 105609, 105620, 105627, 105628, 105667, 105683, 105687, 105689, 105768, 105772, 105778, 105779, 105781, 105782, 105784, 105787, 105788, 105793, 105983, 106004, 106005, 106008, 106017, 106051, 106052, 106076, 106077, 106078, 106393, 106406, 106515, 106625, 106650, 106697.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide, including USA, Argentina, Aruba, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Polynesia, Portugal, Puerto Rico, Qatar, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Tunisia, Turkey, U.S. Virgin Islands, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, and West Indies.
  • 제품 설명
    VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. By using the metallic housing of the pulse generator as an active electrode, combined with the Guidant Endotak two-electrode defibrillation lead, energy is sent via a dual-current pathway from the distal shocking electrode to the proximal electrode and to the pulse generator case. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tacharrhythmias. || Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 551112-5798 USA.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA