Events

Recall of Medtronic Sprint Fidelis Lead

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

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
    45403
  • Event Risk Class
    Class 1
  • Event Number
    Z-0068-2008
  • Event Initiated Date
    2007-10-15
  • Event Date Posted
    2007-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65384
  • 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
    implantable defibrillator lead - Product Code LWS
  • Reason
    Medtronic cardiac rhythm disease management has voluntarily suspended worldwide distribution of the sprint fidelis family of defibrillation leads because of the potential for lead fractures. in addition, the company recommends against new implants of the leads (sprint fidelis models: 6930, 6931, 6948, 6949). medtronic, its independent physician quality panel, and bruce lindsay, m.D., professor of.
  • Action
    A press release was issued by Medtronic on 10/15/2007. An FDA Statement was also issued on 10/15/2007. An Urgent Medical Device Information letter, dated 10/15/2007, was sent to physicians. The letter states that Medtronic has suspended distribution of the leads, the leads should no longer be implanted and unused leads should be returned to Medtronic. This letter describes background information, performance and recommendations. Medtronic believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances. An Important Patient Information letter was addressed to Medtronic Heart Device Patients. Both letters can be found on Medtronic's website at www.medtronic.com/fidelis. Return of product will be achieved with the assistance of Medtronic Representatives.

Device

Medtronic Sprint Fidelis Lead
  • Model / Serial
    all codes
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Puerto Rico, Guam, and Northern Mariana Islands.
  • Product Description
    Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies. Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • Source
    USFDA