Events

Retiro De Equipo (Recall) de Device Recall Cardiac Resynchronization Therapy Defrillator

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
    51345
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1620-2009
  • Fecha de inicio del evento
    2009-03-04
  • Fecha de publicación del evento
    2009-07-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80056
  • 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
    Pulse-generator, dual chamber, implantable - Product Code LWP
  • Causa
    In april 2007, boston scientific crm communicated with physicians regarding the potential for reduced elective replacement indicator (eri) to battery end of life (eol) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. since that time, the april 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrenc.
  • Acción
    Boston Scientific CRM notified Doctors via sales representatives of an "Urgent Medical Device Information" letter dated March 4, 2009. The letter described the problem and included Description of Issue, Rate of Occurrence, Patient Management Recommendations, Devices Affected, Warranty Program & Further Information. A Boston Scientific " Product Advisory" letter dated March 4, 2009, was also made available to physicians to distribute to patients. The letter informed the patient that their defibrillator was included in a group of devices that might experience a performance issue. For further questions, Contact Boston Scientific CRM at 1-800-227-3422.

Device

Device Recall Cardiac Resynchronization Therapy Defrillator
  • Modelo / Serial
    SERIAL NUMBERS FOR MODEL #H170 :  361904, 363420, 363895, 364293, 364294, 364349, 364350, 364470, 364480, 364485, 364486, 364494, 364510, 364539, 364617 and 364621; and  SERIAL NUMBERS MODEL #H175:  312616, 312962, 312965, 312973, 313064, 315207, 315209, 315212, 315213, 315219, 315227, 315238, 315248, 315251, 315265, 315398, 315431, 315446, 316045, 316064 and 316123; and  SERIAL NUMBERS MODEL #H177:  281692, 282937, 284803, 284874, 284896, 285009, 285019, 285091, 285110, 285111, 285120, 285134 285332 and 285357; and  SERIAL NUMBERS MODEL #H179:  111439, 112977, 113822, 113910, 114275, 114375, 114394, 114488, 114503, 114506, 114515, 114523, 114652, 114680, 114682 and 114714; and  SERIAL NUMBERS MODEL #H190:  312166, 311764, 311803, 311894, 312164 and 312177; and  SERIAL NUMBERS MODEL #H195:  352084, 353252, 353389, 351230, 353157 and 353388; and  SERIAL NUMBERS MODEL #H197:  310113, 310253, 310651, 310335, 310337, 310339, 310342, 310357, 310361, 310442, 310464, 310465, 310518, 310660, 310691, 310696, 310814, 310933 and 311096; and  SERIAL NUMBERS MODEL #H199:  321405, 321060, 321415, 321423, 321478, 321489, 321494, 321498 and 321689; and  SERIAL NUMBERS MODEL #M177:  200050 and 200051; and  SERIAL NUMBERS MODEL #M179:  200098, 200099 and 200033.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US including PR and states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, JAPAN, LEBANON, NETHERLANDS, NEW ZEALAND, POLYNESIA, PORTUGAL, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.
  • Descripción del producto
    Guidant Contak¿ Renewal¿ 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO, Guidant Corporation, 4100 Hamline Avenue North, St Paul, MN 55112-5798. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • 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