Recall Z-2120-2011 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc. Cardiac Rhythm Disease Management
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,KDR7
| Date | Apr 29, 2011 (initiated Apr 4, 2011) |
| Status | Terminated |
| 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 |
| Root cause | 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 c |
| Quantity | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.