BEUDAMED
    FDA Recall Terminated

    Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 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 KD700,KD701,KD703,KD706,KDR700,KDR700V,KDR701,KDR701PTO,KDR701V,KDR701VIT,KDR703,KDR703V,KDR706,KDR706V,KDR720,KDR721,KDR730,KDR731,KDR733,KVDD700,KV DD701 Medtronic,Kappa 800 KDR801,KDR803,KDR806 Medtronic,Kappa 900 KD901,KD903,KD906,KDR901,KDR903,KDR906,KDR921,KDR931,KDR933,KVDD901 Medtronic, Enpulse DR E1DR01,E1DR06,E1DR21,E2D01,E2D03,E2DR01,E2DR03,E2DR06,E2DR06J,E2DR21,E2DR21PJ,E2DR31,E2DR31J,E2DR33,E2DR33J,E2VDD01 Medtronic, Adapta/Versa/Sensia DR ADD01,ADDR01,ADDR03,ADDR06,ADDRL1,ADDRS1,ADVDD01,SED01,SED01N,SEDR01,SEDR01N,SEDRL1,VEDR01 Medtronic, Relia RED01,REDR01,REVDD01 (approved in the US but has not been sold in US) Medtronic, Vitatron Extension G and E series DR E50A1,E60A1,G70A1 (not sold in the US)

    Recall: Z-2120-2011 · Initiated April 4, 2011

    Recall

    Recall Number
    Z-2120-2011
    Event Number
    58519
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    FEI Number
    2182208
    Product Code
    NVZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 4, 2011
    Posted
    April 29, 2011
    Terminated
    November 27, 2012
    Address
    8200 Coral Sea St. N.E., Saint Paul, MN, 55112

    Description

    Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 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 KD700,KD701,KD703,KD706,KDR700,KDR700V,KDR701,KDR701PTO,KDR701V,KDR701VIT,KDR703,KDR703V,KDR706,KDR706V,KDR720,KDR721,KDR730,KDR731,KDR733,KVDD700,KV DD701 Medtronic,Kappa 800 KDR801,KDR803,KDR806 Medtronic,Kappa 900 KD901,KD903,KD906,KDR901,KDR903,KDR906,KDR921,KDR931,KDR933,KVDD901 Medtronic, Enpulse DR E1DR01,E1DR06,E1DR21,E2D01,E2D03,E2DR01,E2DR03,E2DR06,E2DR06J,E2DR21,E2DR21PJ,E2DR31,E2DR31J,E2DR33,E2DR33J,E2VDD01 Medtronic, Adapta/Versa/Sensia DR ADD01,ADDR01,ADDR03,ADDR06,ADDRL1,ADDRS1,ADVDD01,SED01,SED01N,SEDR01,SEDR01N,SEDRL1,VEDR01 Medtronic, Relia RED01,REDR01,REVDD01 (approved in the US but has not been sold in US) Medtronic, Vitatron Extension G and E series DR E50A1,E60A1,G70A1 (not sold in the US)

    Reason

    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

    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.

    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).

    Quantity

    1,989,180