Class I Recall of Dual Chamber Implantable Pulse Generators by Medtronic

PUBLISHED: Feb 15, 2019
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Long Term Care, Medical Office

Medtronic is recalling its dual chamber Implantable Pulse Generators (IPGs) due to the possibility of a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death.

Recalled Product Details:

  • Medtronic, Inc. Dual Chamber Implantable Pulse Generators (IPGs)
  • Model Names: Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series
  • Manufacturing Dates: March 2, 2017, to December 18, 2018
  • Distribution Dates: March 6, 2017, to January 7, 2019
  • Devices Recalled in the U.S.: 13,440

Beginning January 17, 2019, Medtronic’s Field Representatives have hand-delivered “Field Corrective Action Notification” letters to implanting and follow-up physicians. The notification provided the following instructions for health care providers:

  • Medtronic recommends programming to a non-susceptible pacing mode as the primary mitigation for patients implanted with an affected device until the software update has been installed.
  • Additional patient risk assessment and programming recommendations are included in Medtronic’s advisory letter, included in the recall notice below.
  • In addition to the field correction notification, Medtronic’s Field Representatives will:
  • Hand deliver an additional “Supplemental Letter” alongside an “Urgent Medical Device Recall” letter to physicians with patients whose devices have shown evidence of a pacing pause that may be related to this circuit error.
  • Request physicians return all unused and unopened affected product to Medtronic for replacement.
  • Confirm notifications are received by implanting or follow-up physicians using Medtronic’s electronic tracking system in conjunction with confirmation via a paper form.
  • Conduct effectiveness checks to ensure that all identified implanting or follow-up physicians and risk managers have been notified or proof of at least three attempts to notify them is obtained.

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