Events

Retiro De Equipo (Recall) de Device Recall INSIGNIA AVT and NEXUS AVT

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Boston Scientific CRM Corp.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    35754
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1296-06
  • Fecha de inicio del evento
    2006-06-24
  • Fecha de publicación del evento
    2006-09-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46733
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Pacemaker - Product Code LWP
  • Causa
    Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or loss of pacing output without warning in the affected devices.
  • Acción
    A Press Release was issued on 06/26/06. An Urgent Medical Device Safety Information & Corrective Action letter, dated 06/23/06 was delivered to physicians describing preliminary information before Guidant has completed its own investigation and finalized patient care recommendations. Non-implanted inventory is being retrieved from hospital shelves and Guidant Represenatatives. Physicians are to perform an in-clinic follow-up exam as soon as possible with patients implanted with affected devices.

Device

Device Recall INSIGNIA AVT and NEXUS AVT
  • Modelo / Serial
    model 482, serial numbers: 101145 thru 101169, 101171 thru 101194, 101196 thru 101201, 101203 thru 101205, 101207 thru 101211, 101214 thru 101246, 101248 thru 101281, 101283 thru 101292, 101296, 101297, 101299 thru 101330, 101332 thru 101360, 101364, 101366, 101367, 101393, 101396, 101397, 101407 thru 101439, 101442 thru 101504, 101507, 101535, 101536.  model 882, serial numbers: 104564, 104565, 104567, 104571, 104575, 104577, 104580, 104583 thru 104654, 104656 thru 104730, 104735, 104737, 104740, 104741, 104744, 104745, 104747, 104749 thru 104775, 104778 thru 104795, 104799 thru 104801, 104807 thru 104812, 104814 thru 104817, 104819 thru 104843, 104845 thru 104867, 104869 thru 104890, 104892 thru 104922, 104925 thru 104930, 104932 thru 104935, 104937 thru 104939, 104944 thru 104948, 104953, 104957 thru 104960, 104973 thru 104975, 104978, 104979, 104989 thru 104992, 104999, 105000, 105009, 105012 thru 105014, 105041, 105044, 105062 thru 105068, 105070 thru 105087, 105090, 105092 thru 105095, 105097 thru 105111, 105113 thru 105115, 105117 thru 105123, 105126 thru 105161, 105163 thru 105168, 105170 thru 105213, 105215 thru 105233, 105235 thru 105260, 105271 thru 105287, 105291, 105293 thru 105330, 105332 thru 105379, 105382 thru 105399, 105401 thru 105450, 105452 thru 105459, 105461 thru 105473, 105475, 105476, 105478 thru 105523, 105525 thru 105534, 105540 thru 105542, 105640.  model 982, serial numbers: 104198 thru 104200, 104202 thru 104210, 104212 thru 104214, 104219, 104220, 104223, 104227 thru 104233, 104250 thru 104257, 104262 thru 104269, 104274 thru 104277, 104279 thru 104282, 104284 thru 104323, 104325 thru 104330, 104332 thru 104338, 104340 thru 104348, 104351, 104353, 104354, 104358 thru 104383, 104386 thru 104388, 104390 thru 104393, 104397, 104398, 104400, 104401, 104422 thru 104456, 104458 thru 104488, 104490 thru 104496, 104498, 104502 thru 104536, 104542 thru 104548, 104550 thru 104553, 104557 thru 104561, 104566, 104567, 104570, 104573, 104578 thru 104580, 104606 thru 104613, 104644, 104658 thru 104660, 104665, 104666, 104668 thru 104670, 104673 thru 104681, 104684 thru 104691, 104694 thru 104732, 104734 thru 104760, 104762 thru 104769, 104771, 104773 thru 104842, 104844 thru 105020, 105022 thru 105029, 105031, 105033 thru 105045, 105048, 105056 thru 105058, 105095, 105104, 105105.   model 1192, serial numbers: 105662 thru 105665, 105676 thru 105682, 105685, 105691, 105692, 105694, 105695, 105697 thru 105702, 105704, 105705, 105707 thru 105711, 105720 thru 105729, 105731 thru 105735, 105737, 105744 thru 105774, 105776 thru 105778, 105780 thru 105798, 105801, 105803 thru 105874, 105876 thru 105906, 105908 thru 105915, 105917, 105918, 105921, 105928 thru 105930, 105933, 105935, 105945, 105956 thru 105959, 105965 thru 105967, 105971, 105974, 105978, 105979, 106020 thru 106234, 106236 thru 106262, 106264 thru 106275, 106283 thru 106286, 106293 thru 106296, 106301, 106304, 106307, 106310, 106313, 106314, 106317, 106319, 106329 thru 106331, 106364, 106370, 106371, 106377, 106378, 106380 thru 106383, 106408 thru 106411, 106419, 106420, 106422 thru 106436, 106438 thru 106469, 106472, 106476 thru 106523, 106525 thru 106546, 106548 thru 106595, 106597 thru 106601, 106603 thru 106649, 106651 thru 106716, 106718, 106719, 106720, 106721, 106722, 106723, 106724, 106725, 106726, 106727, 106728, 106729, 106730, 106731, 106732, 106733, 106734, 106735, 106736, 106737, 106738, 106739, 106740, 106741, 106742, 106743, 106745 thru 106800, 106802 thru 106809, 106811 thru 106850, 106853 thru 106870, 106872 thru 106879, 106882 thru 106903, 106905 thru 106913, 106915, 106917 thru 106920, 106922, 106925 thru 106927, 106930 thru 106933, 106937 thru 106941, 106957, 106961.   model 1292, serial numbers: 106023, 106024, 106027 thru 106029, 106032 thru 106037, 106039, 106041, 106044 thru 106048, 106050 thru 106082, 106087, 106088, 106091, 106099 thru 106104, 106106, 106107, 106123 thru 106128, 106132 thru 106149, 106151, 106156, 106159 thru 106173, 106175, 106177 thru 106187, 106189 thru 106197, 106201, 106206, 106210 thru 106220, 106222 thru 106228, 106231 thru 106246, 106257 thru 106260, 106263 thru 106330, 106332, 106333, 106336, 106338 thru 106342, 106345 thru 106349, 106352, 106359 thru 106361, 106367, 106383 thru 106390, 106395 thru 106398, 106487, 106488, 106490 thru 106674, 106679 thru 106687, 106689 thru 106742, 106783, 106787, 106788, 106794 thru 106798, 106811, 106812, 106815, 106827, 106844, 106847 thru 106850, 106856 thru 106861, 106873, 106877 thru 106890, 106893, 106903, 106904, 106907 thru 106917, 106920, 106921, 106924, 106925, 106927 thru 106929, 106931, 106932, 106934, 106958, 106961, 107012 thru 107015, 107031 thru 107050, 107054 thru 107058, 107060 thru 107079, 107082, 107087 thru 107402, 107404, 107405, 107407 thru 107550, 107552 thru 107581, 107583 thru 107651, 107653 thru 107690, 107692 thru 107699, 107701 thru 107773, 107775 thru 107800, 107802 thru 107816, 107818 thru 107867, 107870 thru 107873, 107875, 107876, 107878, 107880 thru 107882, 107884 thru 107886, 107889 thru 107891, 107908, 107909, 107913, 107916 thru 107922, 107925.   model 1392, serial numbers: 100188 thru 100191, 100196 thru 100200, 100202 thru 100212.   model 1428, serial numbers: 100345 thru 100370, 100372 thru 100376, 100381 thru 100406, 100408 thru 100420, 100422 thru 100428.   model 1432, serial numbers: 100028, 100029, 100030, 100031.   model 1492, serial numbers: 100199 thru 100206, 100219 thru 100254.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    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
  • Descripción del producto
    Guidant INSIGNIA I AVT --family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: VDD (model 1428), DDD (model 1432), SR (model 1392) and DR (model 1492). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant.-- The NEXUS I AVT 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 AVT SSI model 482 = 303; VDD model 882 = 789; DDD model 982 = 656; SR model 1192 = 988; DR model 1292 = 1,408. NEXUS AVT VDD model 1428 = 67; SR model 1392 = 19; DR model 1492 = 39. ****The following devices are not available in the US. *****
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Dirección del fabricante
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA