Events

Avis De Sécurité sur Single Chamber External Pulse Generator

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Medtronic.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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 85 more reports of electrostimulation frequency deviation of programmed value, which may have been related to this problem but were not confirmed due to insufficient data.

Device

Single Chamber External Pulse Generator
  • Modèle / numéro de série
    Model: 5348
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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