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  Class 2 Device Recall KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENIA IPGS see related information
Date Initiated by Firm April 04, 2011
Date Posted April 29, 2011
Recall Status1 Terminated 3 on November 27, 2012
Recall Number Z-2120-2011
Recall Event ID 58519
PMA Number P980035 
Product Classification Pulse generator, permanent, implantable - Product Code NVZ
Product Medtronic, Kappa 600

The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Within each product family, there are varying features, rate responsive pacing, and diagnostic data.

Medtronic,Kappa 700

Medtronic,Kappa 800

Medtronic,Kappa 900

Medtronic, Enpulse DR

Medtronic, Adapta/Versa/Sensia DR

Medtronic, Relia
(approved in the US but has not been sold in US)

Medtronic, Vitatron Extension G and E series DR
(not sold in the US)
Code Information All serial numbers affected.
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
Manufacturer Reason
for Recall
A rare measurement lock-up condition that may (at a rate of approximately 1 in 18,000 devices) inappropriately trigger ERI/RRT in the Medtronic Dual Chamber Pacemakers: Kappa 600, 700, 800, 900, EnPulse, Adapta, Versa, Sensia. This is caused by a random lock-up of the measurement system hardware that may result in an incorrect battery voltage reading of zero. This issue does NOT impact battery lon
FDA Determined
Cause 2
Component design/selection
Action The firm, Medtronic, sent an "Important: Medical Device Correction" letter dated April 2011 to its customers. The letter described the product, problem, and actions taken. Medtronic informed the customers that this issue does NOT impact battery longevity and does NOT require device explant. Currently, the device can be reset to normal operation by a Medtronic representative. Reset devices are no more likely to experience a recurrence of this issue. Medtronic is planning to release a programmer software update that will allow the clinician to reset the device. In addition, Medtronic has consolidated their product performance data with the vision of creating a primary reference tool for performance updates. If you have any questions, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.
Quantity in Commerce 1,989,180
Distribution Worldwide distribution: USA (nationwide) including Guam, Puerto Rico and DC; and countries including: Algeria, Andorra, Anguilla, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belgium, Bermuda, Bolivia, Brazil, Brunei, Darussalam, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Virgin Islands (British).
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. 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. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NVZ and Original Applicant = MEDTRONIC Inc.