Alerta De Seguridad para 5348 Single-Chamber External Pulse Generator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic model 5348 single-chamber external pulse generator medical device manufacturer, medtronic inc., has issued a field safety notice concerning single-chamber external pulse generators (epgs). the affected model is 5348 and the affected serial numbers are within ranges of pep001001p to pep050019p and pep001001k to pep001714k. the manufacturer has identified a performance issue potentially affecting older model 5348 epgs manufactured between july 1995 and december 2007. this issue does not affect any other epg models or any medtronic implantable devices. through 16 april 2014, the manufacturer has determined 49 events (out of approximately 30,000 potentially affected 5348 epgs, or 0.16 percent), were related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm). the root cause of this issue is the development of high resistance on internal electrical connector contacts due to oxidation over time. due to the unpredictable nature of the oxidation process on multiple electrical contacts, this issue may result in one or more of the following observations: pacing rate outside of the intended setting, potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm. output amplitude or sensitivity outside of intended setting. pace, sense, or low battery led indicators not lighting during power on or reset functions. rapid atrial pacing (rap) display with intermittent functionality. intermittent functionality of the on/off and rap control button. the manufacturer recommends the following actions be taken when using a potentially affected model 5348 epg: monitor the epg function and patient’s heart rhythm continuously while the epg is in use to ensure it is operating properly and delivering appropriate therapy to the patient. if any malfunction is observed with a 5348 epg, ensure the patient’s condition is stabilized, discontinue use of the model 5348 device and contact the manufacturer. according to the manufacturer, they will no longer service or repair epgs that are more than five years old, including these potentially affected 5348 epgs; which is consistent with the five-year service life of the new model 5392 epg. the manufacturer will separately communicate additional details about this new epg service policy. the manufacturer advises customers to contact them for assistance with purchasing a replacement device if customers choose to replace their potentially affected 5348 epg. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 5 may 2014.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Model 5348 Single-Chamber External Pulse Generator
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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