Single Chamber Temporary External Pacemaker

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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.
  • Manufacturers representative
    Tamer Frères S.A.L.
  • Source
    RLMPH

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Affected devices include Model 53401 EPGs with serial numbers lower than MDB05000 that were distributed between February 2017 and November 2017.
  • Product Description
    Pacemaker, cardiac, external, invasive
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Single Chamber Temporary External Pacemaker 53401
  • Manufacturer