Saint Paul MN 55112: For Additional Information Contact: 76 Manufacturer Reason for Recall: Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. PMAs with Product Code = DXY and Original Applicant = MEDTRONIC Inc. Cardiac Rhythm Disease Managment 8200 Coral Sea St. Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. OUS: Customers in the following countries: Andorra, Argentina, Aruba, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Brunei, Darussalam, Canada, Cayman Islands, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, Viet Nam, Virgin Islandsġ A record in this database is created when a firm initiates a correction or removal action. For additional information or assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 80.Īll States in the USA including Guam, Puerto Rico and DC. At this time, no other action, reprogramming or change in the frequency of follow-up is recommended. The letter included recommendations including that Medtronic recommends physicians continue to use the ERI notification to determine time for device replacement. In the letter, Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. The software will eliminate this issue, foĬonsignees were given a Medtronic "Important : Medical Device Correction" letter addressed to "Dear Doctor" and dated February 2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured at: Juncos, Puerto Rico, USA. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. ![]() Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. ![]() Implantable pacemaker pulse-generator - Product Code DXY You can find the date that a firm initiated a recall in the text of the recall notice.Class 2 Device Recall Medtronic EnRhythm pacemaker Please note that the FDA lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. The links give details about what to do if you own or use one of these products. Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to patients. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. ![]() The FDA posts summaries of information about the most serious medical device recalls.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |