Events

Retiro De Equipo (Recall) de Device Recall SICD Programmer

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 Corporation.

¿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
    76323
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1178-2017
  • Fecha de inicio del evento
    2017-01-12
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152779
  • 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
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • Causa
    There is a potential for radio frequency (rf) interference to alter wireless communication from a programmer, which in rare instances may cause an s-icd to perform an unintended command. this behavior can only occur during an active, in-clinic interrogation/programming session with the model 3200 s-icd programmer. there is no risk of this behavior occurring when the latitude patient management system communicates with an s-icd in an ambulatory setting.
  • Acción
    Boston Scientific sent an "Important Medical Device Information" letter dated on January 12, 2017. The letter was addressed to "Dear Doctor". The letter included information on the Description and Clinical Implications, Rate of Occurrence, Recommendations, Affected Programmer & Additional Information. For additional questions regarding this communication or to report clinical events, contact your Boston Scientific representative or Technical Services at 1 800-227-3422.

Device

Device Recall SICD Programmer
  • Modelo / Serial
    All serial numbers.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA ( nationwide) including PR and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY., and to the countries of :Canada, Austria, Belgium, Czech Republic, Denmark, Finland, France, French Polynesia, Guadeloupe, Monaco, New Caledonia, Reunion, Germany, Greece, Hungary, Ireland, Israel, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Australia, China, Egypt, Hong Kong, India, Iran, Japan, Jordan, Kuwait, Lebanon, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, South Africa, Thailand, Tunisia, Turkey, United Arab Emirates, Argentina, Bermuda and Brazil.
  • Descripción del producto
    Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA