BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2209-2010 · Initiated June 11, 2010

    Recall

    Recall Number
    Z-2209-2010
    Event Number
    56118
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Managment
    FEI Number
    2182208
    Product Code
    NVZ
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    June 11, 2010
    Posted
    August 11, 2010
    Terminated
    December 24, 2011
    Address
    8200 Coral Sea St. N.E., Saint Paul, MN, 55112

    Description

    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.

    Reason

    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.

    Action

    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.

    Distribution

    International Distribution Only: Australia and Canada.

    Quantity

    37 Foreign, 0 Domestic