Events

Recall of VERSA DUAL CHAMBER RATE RESPONSIVE PACEMAKER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    123037
  • Event Risk Class
    II
  • Event Initiated Date
    2011-05-03
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The purpose of this action is inform physicians who have implanted or follow patients implanted with dual chamber pacemakers about a rare approximately 1 in 18000 devices measurement lock-up condition that may inappropriately trigger eri/rrt in specific medtronic dual chamber pacemakers. in rare instances these devices exhibit a condition in which the hardware component of the measurement system may lock up resulting in the device declaring eri (elective replacement indicator)/rrt (recommended replacement time). this device then inappropriately defaults to an eri state. when devices exhibit this condition they do not actually have a depleted battery but rather the device displays eri due to the erroneous voltage measurement. when the false eri occurs the device is reverted to a defined set of parameters (vvi mode at 65 beats per minute). a device exhibiting thiscondition can be resolved through the use of a specially configured programmer and software reset application to clear the eri/rrt condition. the ipg is not modified but simply returned to its previous settings. it should be noted that this issue does not shorten the actual device longevity after a reset.

Device

VERSA DUAL CHAMBER RATE RESPONSIVE PACEMAKER
  • Model / Serial
    Model Catalog: VEDR01 (Lot serial: >10 contact manufacturer); Model Catalog: KDR906 (Lot serial: >10 contact manufacturer); Model Catalog: E2D03 (Lot serial: >10 contact manufacturer); Model Catalog: KDR931 (Lot serial: >10 contact manufacturer); Model Catalog: KDR903 (Lot serial: >10 contact manufacturer); Model Catalog: KDR933 (Lot serial: >10 contact manufacturer); Model Catalog: KDR803 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR33 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR31 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR21 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR06 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR03 (Lot serial: >10 contact manufacturer); Model Catalog: E2DR01 (Lot serial: >10 contact manufacturer); Model Catalog: KD703 (Lot serial: >10 contact manufacturer); Model Catalog: PHM621259S (Lot serial: >10 contact manufacturer); Model Catalog: REVDD01 (Lot serial: >10 contact manufacturer); Model Catalog: KDR706 (Lot s
  • Product Description
    VERSA DUAL CHAMBER RATE RESPONSIVE PACEMAKER
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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.
  • Source
    HC