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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0088-2015

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

Publicado el 29 de octubre de 2014 · Inicio del retiro: 17 de septiembre de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt

Qué hacer

Voluntary: Firm initiated · Visit

Detalles del retiro

Fabricante
Boston Scientific CRM Corp
Distribuidor
Worldwide Distribution - US Nationwide including American Samoa, Guam, Puerto Rico, and U.S. - Virgin Islands. OUS countries to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Mozambique, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, North Yemen, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan R O C, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
Lote
Model E102 - Serial Numbers: 240307, 240308, 240310, 240312, 240313, 240318, 240319, 240320, 240321, 240324, 240325, 240326, 240327, 240329, 240330, 240332, 240336, 240338, 240340, 240342, 240344, 240345, 240346, 240348, 240349, 240350, 240351, 240354, 240355, 240356, 240358, 240359, 240360, 240363, 240365, 240366, 240367, 240368, 240369, 240371, 240372, 240373, 240374, 240375, 240376, 240378, 240380, 240383, 240384, 240386, 240389, 240391, 240393, 240397, 240398, 240399, 240401, 240403, 240404, 240405, 240406, 240407, 240408, 240410, 240414, 240415, 240416, 240418, 240421, 240422, 240423, 240424, 240426, 240432, 240433, 240434, 240438, 240439, 240441, 240443, 240444, 240448, 240450, 240451, 240452, 240454, 240455, 240456, 240457, 240459, 240460, 240461, 240462, 240466, 240468, 240471, 240472, 240473, 240474, 240475, 240478, 240479, 240480, 240484, 240485, 240488, 240489, 240490, 240491, 240492, 240493, 240496, 240497, 240500, 240501, 240503, 240505, 240508, 240510, 240511, 240512, 240517, 240519, 240521, 240523, 240524, 240525, 240527, 240529, 240530, 240531, 240533, 240535, 240536, 240537, 240540, 240542, 240544, 240547, 240548, 240549, 240550, 240551, 240552, 240555, 240556, 240557, 240558, 240559, 240561, 240562, 240563, 240566, 240573, 240575, 240576, 240579, 240582, 240583, 240584, 240586, 240587, 240589, 240590, 240591, 240592, 240593, 240594, 240596, 240597, 240598, 240599, 240600, 240602, 240605, 240606, 240607, 240608, 240609, 240610, 240611, 240612, 240615, 240616, 240618, 240619, 240622, 240623, 240624, 240627, 240628, 240630, 240633, 240635, 240636, 240637, 240639, 240640, 240641, 240642, 240644, 240645, 240646, 240647, 240648, 240649, 240650, 240652, 240653, 240655, 240656, 240657, 240658, 240659, 240660, 240663, 240664, 240665, 240666, 240668, 240669, 240672, 240674, 240678, 240679, 240680, 240681, 240687, 240688, 240690, 240692, 240699, 240701, 240703, 240705, 240707, 240708, 240709, 240712, 240713, 240715, 240717, 240718, 240719, 240720, 240722, 240723, 240725, 240726, 240727, 240728, 240729, 240730, 240731, 240732, 240736, 240737, 240738, 240740, 240741, 240743, 240744, 240747, 240749, 240750, 240751, 240752, 240755, 240757, 240758, 240759, 240761, 240762, 240763, 240764, 240765, 240766, 240767, 240768, 240769, 240770, 240771, 240775, 240777, 240778, 240779, 240780, 240781, 240782, 240788, 240791, 240792, 240794, 240797, 240798, 240799, 240800, 240801, 240802, 240803, 240804, 240805, 240806, 240807, 240808, 240810, 240814, 240818, 240821, 240822, 240826, 240828, 240829, 240830, 240832, 240833, 240834, 240835, 240836, 240837, 240840, 240841, 240844, 240845, 240848, 240849, 240850, 240851, 240852, 240853, 240854, 240855, 240858, 240859, 240861, 240862, 240863, 240864, 240865, 240868, 240869, 240870, 240872, 240873, 240874, 240875, 240876, 240877, 240878, 240879, 240881, 240882, 240883, 240884, 240886, 240889, 240890, 240891, 240893, 240894, 240895, 240896, 240897, 240898, 240899, 240900, 240901, 240902, 240903, 240905, 240906, 240910, 240912, 240913, 240914, 240916, 240917, 240918, 240924, 240928, 240932, 240934, 240939, 240941, 240942, 240943, 240944, 240945, 240946, 240949, 240950, 240952, 240953, 240954, 240955, 240956, 240957, 240959, 240960, 240961, 240962, 240965, 240966, 240968, 240969, 240971, 240973, 240975, 240976, 240977, 240979, 240980, 240981, 240982, 240985, 240988, 240990, 240991, 240992, 240993, 240995, 240996, 240997, 240999, 241000, 241001, 241003, 241004, 241005, 241006, 241007, 241010, 241012, 241014, 241017, 241020, 241022, 241023, 241026, 241027, 241028, 241029, 241030, 241031, 241032, 241033, 241034, 241037, 241038, 241039, 241041, 241042, 241044, 241045, 241048, 241050, 241051, 241053, 241054, 241056, 241058, 241060, 241061, 241063, 241064, 241065, 241069, 241074, 241076, 241077, 241079, 241082, 241083, 241085, 241086, 241088, 241089, 241090, 241092, 241093, 241095, 241096, 241097, 241098, 241100, 241101, 241102, 241103, 241104, 241106, 241107, 241108, 241109, 241112, 241113, 241114,
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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