FDA Device

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 M

Hazard

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

What You Should Do

Remedy

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.

Products

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 fam
Brand
Medtronic Inc. Cardiac Rhythm Disease Management
UPC
All serial numbers affected.

Units Affected

1,989,180