Events

Notificaciones De Seguridad De Campo acerca de Single Chamber External Pulse Generator

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Medtronic Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2014-04-29
  • Fecha de publicación del evento
    2014-05-19
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2014/05/19/vazno-obavestenje-o-medicinskom-sredstvu-single-chamber-external-pulse-generator-model-5348-pejsmejker/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Notas adicionales en la data
  • Causa
    Medtronic has detected a problem with a device potentially affecting older single-chamber temporary pacemakers ("epgs") model 5348, manufactured between july 1995 and december 2007. by april 16, 2014, medtronic identified 49 adverse events (out of about 30,000 potentially affected model 5348 epgs, or 0.16 percent) that related to a deviation from the programmed electrostimulation frequency, including sudden events elevated electrostimulation frequencies up to a maximum of 180 beats per minute. of those 49 events, (two cases were reported in france and the other 47 were reported outside the eu), one was associated with the death of patients and no other critical injury reports were reported. the manufacturer has received another 85 reports of a programmed frequency deviation from the programmed value, which could be related to this problem but were not confirmed due to insufficient data.

Device

Single Chamber External Pulse Generator
  • Modelo / Serial
    Model: 5348from PEP001001P to PEP050019P and from PEP001001K to PEP001714K
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • 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
    ALIMSA