Events

Recall of Device Recall Medtronic SIGMA 100/200/300 Series IPGs

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 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
    52076
  • Event Risk Class
    Class 1
  • Event Number
    Z-1510-2009
  • Event Initiated Date
    2009-05-18
  • Event Date Posted
    2009-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82036
  • 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 Pacemakere Pulse-Generator - Product Code DXY
  • Reason
    One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. this may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.
  • Action
    Medtronic Sales representative hand delivered an Important Patient Safety Information letter, dated May 2009, to physicians beginning 05/18/09. The letter describes the issues, provides a predicted failure rate for the 3 populations of devices, and provides Patient Management Recommendations. The letter recommended that physicians should advise their patients to seek medical attention immediately if they experience symptoms (e.g., fainting or lightheadedness). It was also recommended that physicians should consider device replacement for patients who are both pacemaker dependent and who have been implanted with a device in the affected subsets. Medtronic will offer supplemental device warranty if the device is not already at elective replacement time. The last recommendation was that physicians should continue routine follow up in accordance with standard practice for those patients who are not pacemaker dependent. The letter also provides Physician and Patient Support. Letters will be mailed to patients with registered devices beginning 05/27/09. Questions should be directed to a local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

Device

Device Recall Medtronic SIGMA 100/200/300 Series IPGs
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including Washington D.C., Guam, Puerto Rico, and Virgin Islands; Albania, Algeria, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latin America, Latvia, Lebanon, Luxembourg, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, Norway, Oman, Pakistan, Palestinian Territory Occupied, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vatican City State (Holy See), and Venezuela.
  • Product Description
    Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Managment
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Managment, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • 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