Events

Recall of Medtronic Medical Device Identification Card

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Disease Management.

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
    72245
  • Event Risk Class
    Class 2
  • Event Number
    Z-0022-2016
  • Event Initiated Date
    2015-09-15
  • Event Date Posted
    2015-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140324
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    permanent pacemaker Electrode ID card - Product Code DTB
  • Reason
    Some medical device identification cards provided to surescan pacemaker patients indicate they have a complete magnetic resonance (mr) conditional system, when in fact, not all of their implanted leads have been fda approved as mr conditional.
  • Action
    On September 15, 2015, Medtronic began mailing an Important Medical Device Identification Card Notification letter, including a corrected Medical Device Identification Card, to impacted patients. The letter described the issue, provided a new corrected Identification Card, asked that the old card be destroyed immediately, and to begin using the new card. Patients can contact Medtronic Patient Services at 1-800-551-5544, option 1, followed by option 3, Monday - Friday, 8am - 5pm Central time.

Device

Medtronic Medical Device Identification Card
  • Model / Serial
    no codes on the cards
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US nationwide distribution.
  • Product Description
    Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 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
    USFDA