Events

Retiro De Equipo (Recall) de Merlin PCS Programmer Software

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 St Jude Medical Inc..

¿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
    80244
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2335-2018
  • Fecha de inicio del evento
    2018-04-16
  • 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=165010
  • 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
    Recorder, event, implantable cardiac, (without arrhythmia detection) - Product Code MXC
  • Causa
    The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of confirm rx model dm3500 insertable cardiac monitoring (icm) devices. this drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
  • Acción
    The firm, Abbott, sent an "URGENT MEDICAL DEVICE CORRECTION" letters dated 05/18/2018, to its consignees notifying them that updated programmer software version 24.2.x will be made available over the next several weeks and will allow physicians to detect the presence of incorrect battery indicator prior to implant. Additionally, the programmer software will provide a mechanism to resolve the incorrect display for already implanted devices. If a low battery indicator is observed, customers were advised to contact firm technical services at 1-800-722-3774 to assist in confirmation and correction of the battery indicator display.

Device

Merlin PCS Programmer Software
  • Modelo / Serial
    Software Versions: 24.0.1 rev 1
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    U.S. Nationwide Distribution: PR, MI, NJ, IL, FL, AR, PA, KY, CA, TN, IN, AL, TX, AZ, SC, OK, VA, NH, NM, WA, CO, IA, WI, NV, UT, OH, NC, MO, DE, WV, MD, OR, NE, VT, KS, MA, IA, WY, CT, GA, MS, LA, DC, LA,
  • Descripción del producto
    Merlin PCS Programmer Software: 3330 || The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
  • Manufacturer
    St Jude Medical Inc.

Manufacturer

St Jude Medical Inc.
  • Dirección del fabricante
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA