BEUDAMED
    FDA Recall Open, Classified

    Medtronic SynchroMed II, Model 8637-40, Programmable pump

    Recall: Z-0615-2024 · Initiated November 13, 2023

    Recall

    Recall Number
    Z-0615-2024
    Event Number
    93481
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 13, 2023
    Posted
    December 22, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Medtronic SynchroMed II, Model 8637-40, Programmable pump

    Reason

    Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

    Action

    Medtronic issued an URGENT MEDICAL DEVICE CORRECTION notice to healthcare providers and medical facilities on 77/13/2023 via mail and email. The notice explained the problem with the device, hazards to patient, and recommended the following: Patient Management Recommendations: . Upon completion of an MRI scan, interrogate the pump with the Clinician Programmer (or Personal Therapy Manager) to end telemetry mode and resume drug delivery. . Consult the MRI Guidelines for additional information on MRI preparation and post-examination review, and motor stall recovery timing (see MRI Guidelines at www.manuals.medtronic.com). . Remind your patients about the importance of interrogating the SynchroMed II pump after an MRI to ensure continuation of therapy. . Educate patients, caregivers, and family members to recognize the signs and symptoms associated with intrathecal drug therapy underdose or withdrawal. Patients receiving intrathecal baclofen therapy (e.g., Lioresal Intrathecal) are at higher risk for adverse events, as baclofen withdrawal can lead to a life-threatening condition if not treated promptly and effectively. For questions or concerns associated with this correction, please contact your Medtronic Representative or Technical Services at 1-800-707-0933. On 07/10/2024, Medtronic sent an additional notification to customers to correct an error in the previous communication. The previous communication incorrectly included a reference to the use of the Patient Therapy Manager as part of the recommended mitigations. The updated communication has been revised to remove reference to the Patient Therapy Manager. All other aspects of the mitigations remain unchanged.

    Distribution

    Worldwide

    Quantity

    78532 units