||August 11, 2010
||Terminated on December 24, 2011
|Recall Event ID
Pulse Generator, Permanent, Implantable - Product Code NVZ
||Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free number. The monitor can also send wireless heart device alerts to the clinic automatically.
||Lot Serial No
|Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
|Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional.
No patient injuries have been reported as a result of this issue.
|CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
||Starting on 6/11/2010, Medtronic began sending Australian and Canadian consignees "Medical Device Recall" letters dated 6/10/2010. The letters describe the problem and product involved. The letters instructs consignees to order replacement monitors, notify affected patients, and instruct each patient to perform a manual transmission upon receipt of the new monitor.
Medtronic will provide affected patients with a prepaid return kit to faciliate the return of the monitor to Medtronic.
Australian consignees should contact Scott Dunlop at 61-7 3025-3547. Canadian consignees should contact Medtronic Patient Services at 1-800-268-5346.
|Quantity in Commerce
||37 Foreign, 0 Domestic
||International Distribution Only: Australia and Canada.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMAs with Product Code = NVZ and Applicant = MEDTRONIC INC.
PMAs with Product Code = NVZ and Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = NVZ and Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = NVZ and Applicant = MEDTRONIC, INC.