Events

Retiro De Equipo (Recall) de Device Recall Medtronic SynchroMed EL implantable drug pump

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. - Neuromodulation.

¿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
    57651
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1062-2011
  • Fecha de inicio del evento
    2011-01-14
  • Fecha de publicación del evento
    2011-02-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96919
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Causa
    This letter provides important reminders concerning the potential for a pocket fill during a synchromed¿ ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations that will be added to our product labeling. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patients subcutaneous tissue, which includes the pum.
  • Acción
    The firm, Medtronic, sent an "Urgent Medical Device Correction Cover " letter dated January 2011 to all customers. Enclosed with each letter, an "Urgent Medical Device Correction Important Clinical Information about Pocket Fills" letter dated January 2011 as well as a Clinician Refill Reference Card, Refill Appointment Cards, Physician Reply Card and a Self Addressed Stamped Envelope. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to always check the needle placement within the pump septum throughout the procedure to help perform a successful refill; be aware that the pump refill difficulty may increase due to a variety of factors (listed); monitor the patient closely for signs and symptoms of overdose according to the provided instructions. Note: Medtronic is in the process of supplementing the labeling related to improper injection with the information included in this communication. Patients with questions are encouraged to talk with their physician or contact Medtronic Patient Services at 1-800-510-6735, Monday - Friday, 8 a.m. to 5 p.m. CDT. Physicians with medical questions related to this issue or Medtronic therapies should contact Medtronic at 1-800-328-0810, Monday - Friday, 8 a.m. to 5 p.m. CDT. UPDATE - June 2013 - Medtronic Field Representative began notifying Healthcare Professionals June 3,2013,via visit to deliver and discuss the Pump Refill Procedure Safety Update letter. The letter informs clinicians that SynchroMed Implantable Infusion System labeling and the Clinician Refill Reference Card have been updated. The labeling and reference card were updated to provide important reminders concerning the potential for a pocket fill during a SynchroMed II or SynchroMed EL implantable drug pump refill procedure. The Medtronic Rep will complete a Physician Notification Confirmation form documenting the delivery of the information. A copy of the recall notification letter a

Device

Device Recall Medtronic SynchroMed EL implantable drug pump
  • Modelo / Serial
    All units of these pump models are affected. Updates will be conducted on the Labeling, Training and Education Materials and the Refill Template which is included with the refill kits wil be redesigned.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including DC and PR and countries including: AUSTRALIA, NEW ZEALAND, HONG KONG, TAIWAN, CHINA, SINGAPORE, MALAYSIA, INDONESIA, SOUTH KOREA, THAILAND, ARUBA, AUSTRIA, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, FAROE ISLANDS, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JORDAN, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NETHERLANDS ANTI LES, NORWAY, PANAMA, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAN MARINO, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VATICAN CITY.
  • Descripción del producto
    Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump || The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.
  • Manufacturer
    Medtronic, Inc. - Neuromodulation

Manufacturer

Medtronic, Inc. - Neuromodulation
  • Dirección del fabricante
    Medtronic, Inc. - Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 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