Events

Retiro De Equipo (Recall) de Device Recall Medtronic SIGMA 100/200/300 Series IPGs

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 Medtronic Inc. Cardiac Rhythm Disease Managment.

¿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
    52076
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1510-2009
  • Fecha de inicio del evento
    2009-05-18
  • Fecha de publicación del evento
    2009-06-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82036
  • 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 Pacemakere Pulse-Generator - Product Code DXY
  • Causa
    One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. this may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
  • Acción
    Medtronic Sales representative hand delivered an Important Patient Safety Information letter, dated May 2009, to physicians beginning 05/18/09. The letter describes the issues, provides a predicted failure rate for the 3 populations of devices, and provides Patient Management Recommendations. The letter recommended that physicians should advise their patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness). It was also recommended that physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets. Medtronic will offer supplemental device warranty if the device is not already at elective replacement time. The last recommendation was that physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent. The letter also provides Physician and Patient Support. Letters will be mailed to patients with registered devices beginning 05/27/09. Questions should be directed to a local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

Device

Device Recall Medtronic SIGMA 100/200/300 Series IPGs
  • Modelo / Serial
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including Washington D.C., Guam, Puerto Rico, and Virgin Islands; Albania, Algeria, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latin America, Latvia, Lebanon, Luxembourg, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, Norway, Oman, Pakistan, Palestinian Territory Occupied, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vatican City State (Holy See), and Venezuela.
  • Descripción del producto
    Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Managment
  • Dirección del fabricante
    Medtronic Inc. Cardiac Rhythm Disease Managment, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA