Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.
This recall has been terminated (originally issued April 26, 2010).
- Recall Initiated
- February 11, 2010
- Posted
- April 26, 2010
- Terminated
- January 8, 2013
- Recall Number
- Z-1440-2010
- Quantity
- approximately 120,061 worldwide
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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. 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. The software will eliminate this issue, fo
Distribution
All States in the USA including Guam, Puerto Rico and DC. 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 Islands
Lot / Code Info
All EnRhythm pacemakers
Root Cause
Nonconforming Material/Component
Action Taken
Consignees were given a Medtronic "Important : Medical Device Correction" letter addressed to "Dear Doctor" and dated February 2010. 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 letter included recommendations including that Medtronic recommends physicians continue to use the ERI notification to determine time for device replacement. At this time, no other action, reprogramming or change in the frequency of follow-up is recommended. For additional information or assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.