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Medtronic, Kappa 600 recallZ-2120-2011 · Medtronic Inc. Cardiac Rhythm Disease Management · initiated Apr 4, 2011

Terminated All recalls posted in April 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc. Cardiac Rhythm Disease Management or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-2120-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 4, 2011
Posted by the FDA
Apr 29, 2011
Recalling firm
Medtronic Inc. Cardiac Rhythm Disease Management
Quantity
1,989,180
Product code
NVZ
FDA submissions
P980035
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).

Product 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)

Code information (models, lots, serial numbers)

All serial numbers affected.

Other devices under the same FDA submission

71 devices cleared under P980035 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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